This position is responsible for providing technical leadership within the process engineering department for equipment and process design for Seqirus Liverpools products ensuring the engineering solutions meet cost, reliability, schedule, and performance integrity requirements. Additionally, this position is responsible for the planning and execution of all process engineering activities from pre click apply for full job details
Oct 09, 2025
Full time
This position is responsible for providing technical leadership within the process engineering department for equipment and process design for Seqirus Liverpools products ensuring the engineering solutions meet cost, reliability, schedule, and performance integrity requirements. Additionally, this position is responsible for the planning and execution of all process engineering activities from pre click apply for full job details
This role will provide Supervisory support for the Facilities Lead of Seqirus Vaccines Ltd. To ensure delivery of effective support services so the business remains competitive and lean to deliver Seasonal and Global Pandemic Influenza Vaccines across the globe. The Support services across the Liverpool Sites cover, but not limited to, Facilities Maintenance, Mechanical and Electrical, Compliance M click apply for full job details
Oct 09, 2025
Full time
This role will provide Supervisory support for the Facilities Lead of Seqirus Vaccines Ltd. To ensure delivery of effective support services so the business remains competitive and lean to deliver Seasonal and Global Pandemic Influenza Vaccines across the globe. The Support services across the Liverpool Sites cover, but not limited to, Facilities Maintenance, Mechanical and Electrical, Compliance M click apply for full job details
The Position: The R&D Data Excellence Lead drives the vision, strategy, and execution of data excellence across the R&D organization. This role ensures that data is standardized, governed, and leveraged for advanced insights across scientific, clinical, safety, and regulatory domains. The role serves as a strategic advisor to R&D leadership, overseeing enterprise-aligned data infrastructure, data architecture, and standards to accelerate discovery, development, and decision-making. The role partners closely with enterprise I&T to ensure all data initiatives are scalable, compliant, and interoperable. Responsibilities: Define and execute the R&D-wide data and analytics strategy aligned to R&D 2.0 transformation goals and PD&C objectives Serve as a strategic advisor to R&D leadership on opportunities to improve pipeline productivity and operational efficiency using data Establish and govern data standards, metadata management, lineage, and ontologies across R&D domains Ensure compliance with enterprise data governance and facilitate its application across R&D data sets Partner with I&T to design and maintain scalable, secure, and interoperable data platforms Enable integration of diverse data types including clinical, real-world data, omics, imaging, and digital biomarkers Collaborate with Digital Business Partners and Analytics teams to ensure data readiness and accessibility for advanced analytics Foster cross-functional data alignment across clinical, safety, regulatory, and research domains Lead and develop a high-performing team of data stewards, scientists, and architects Engage external partners, consortia, and regulatory bodies to influence and align with industry data innovation Education & Requirements: Advanced degree (MS, PhD, or equivalent) in Data Science, Bioinformatics, Statistics, Computer Science, or a related field. 10+ years of data strategy and analytics experience in life sciences industry, with 5+ years in a leadership capacity. Strong knowledge of R&D processes, including discovery, translational, clinical development, and regulatory submissions Proven experience in enterprise data governance, architecture, and platform design in GxP environments. Familiarity with AI/ML enablement, though not focused on algorithm development. Strong stakeholder engagement, communication, and change leadership skills. Expertise with modern data stack: cloud platforms, data lakes, FAIR principles, and standards like CDISC, HL7/FHIR Our Benefits CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals. Please take the time to review our benefits site to see what's available to you as a CSL employee. About CSL Behring CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring . We want CSL to reflect the world around us At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. Learn more Inclusion and Belonging CSL . Do work that matters at CSL Behring!
Oct 04, 2025
Full time
The Position: The R&D Data Excellence Lead drives the vision, strategy, and execution of data excellence across the R&D organization. This role ensures that data is standardized, governed, and leveraged for advanced insights across scientific, clinical, safety, and regulatory domains. The role serves as a strategic advisor to R&D leadership, overseeing enterprise-aligned data infrastructure, data architecture, and standards to accelerate discovery, development, and decision-making. The role partners closely with enterprise I&T to ensure all data initiatives are scalable, compliant, and interoperable. Responsibilities: Define and execute the R&D-wide data and analytics strategy aligned to R&D 2.0 transformation goals and PD&C objectives Serve as a strategic advisor to R&D leadership on opportunities to improve pipeline productivity and operational efficiency using data Establish and govern data standards, metadata management, lineage, and ontologies across R&D domains Ensure compliance with enterprise data governance and facilitate its application across R&D data sets Partner with I&T to design and maintain scalable, secure, and interoperable data platforms Enable integration of diverse data types including clinical, real-world data, omics, imaging, and digital biomarkers Collaborate with Digital Business Partners and Analytics teams to ensure data readiness and accessibility for advanced analytics Foster cross-functional data alignment across clinical, safety, regulatory, and research domains Lead and develop a high-performing team of data stewards, scientists, and architects Engage external partners, consortia, and regulatory bodies to influence and align with industry data innovation Education & Requirements: Advanced degree (MS, PhD, or equivalent) in Data Science, Bioinformatics, Statistics, Computer Science, or a related field. 10+ years of data strategy and analytics experience in life sciences industry, with 5+ years in a leadership capacity. Strong knowledge of R&D processes, including discovery, translational, clinical development, and regulatory submissions Proven experience in enterprise data governance, architecture, and platform design in GxP environments. Familiarity with AI/ML enablement, though not focused on algorithm development. Strong stakeholder engagement, communication, and change leadership skills. Expertise with modern data stack: cloud platforms, data lakes, FAIR principles, and standards like CDISC, HL7/FHIR Our Benefits CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals. Please take the time to review our benefits site to see what's available to you as a CSL employee. About CSL Behring CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring . We want CSL to reflect the world around us At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. Learn more Inclusion and Belonging CSL . Do work that matters at CSL Behring!
The Position: The R&D Digital Strategy and Delivery Lead ensures that the digital portfolio across R&D is planned, executed, and tracked effectively to maximize business value. This role is responsible for governance, operational excellence, and strategic planning for TES initiatives, including program management, vendor oversight, and value realization tracking. The role partners with digital leaders, I&T, and finance to ensure disciplined delivery of the digital roadmap and portfolio transparency. This role will oversee the platform operations vendor relationship, as well as key R&D Technology Enabled Science vendor partnerships, in close collaboration with the PPE organization. The role also provides strategic oversight of R&D digital architecture to ensure scalable, integrated, and future-ready solutions aligned with enterprise technology standards. Responsibilities: Lead end-to-end portfolio management of R&D digital projects, ensuring alignment to R&D strategy and TES vision Manage governance structures, including steering committees and working groups, to oversee execution Monitor program performance, timelines, budgets, and ROI metrics using digital portfolio tools Oversee operational processes and ensure adherence to quality and compliance standards Manage key vendor and service provider relationships in partnership with PPE, procurement and finance Support strategic planning and scenario analysis by integrating business needs with digital capabilities Lead change management efforts to drive adoption of digital tools and ways of working Provide executive reporting on digital progress and impact across R&D organization and the broader enterprise Provide leadership and governance for R&D digital architecture, ensuring consistency, scalability, interoperability, and alignment with enterprise IT frameworks and digital strategies Education & Requirements: 12+ years of experience in digital transformation, PMO, or portfolio management within R&D, biotech, or pharma Proven experience managing cross-functional digital programs or portfolios. Demonstrated success in managing cross-functional initiatives and complex program portfolios Strong operational and planning acumen, with knowledge of portfolio management tools (e.g., Planview, Smartsheet, Jira) Understanding of R&D processes and digital strategy trends in the life sciences sector Experience in digital architecture strategy, solution design, or enterprise architecture within R&D, with strong understanding of integration patterns, data flows, and platform scalability Experience with vendor and external partner governance Strong communication, change leadership, and executive reporting capabilities Our Benefits CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals. Please take the time to review our benefits site to see what's available to you as a CSL employee. About CSL Behring CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring . We want CSL to reflect the world around us At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. Learn more Inclusion and Belonging CSL . Do work that matters at CSL Behring!
Oct 04, 2025
Full time
The Position: The R&D Digital Strategy and Delivery Lead ensures that the digital portfolio across R&D is planned, executed, and tracked effectively to maximize business value. This role is responsible for governance, operational excellence, and strategic planning for TES initiatives, including program management, vendor oversight, and value realization tracking. The role partners with digital leaders, I&T, and finance to ensure disciplined delivery of the digital roadmap and portfolio transparency. This role will oversee the platform operations vendor relationship, as well as key R&D Technology Enabled Science vendor partnerships, in close collaboration with the PPE organization. The role also provides strategic oversight of R&D digital architecture to ensure scalable, integrated, and future-ready solutions aligned with enterprise technology standards. Responsibilities: Lead end-to-end portfolio management of R&D digital projects, ensuring alignment to R&D strategy and TES vision Manage governance structures, including steering committees and working groups, to oversee execution Monitor program performance, timelines, budgets, and ROI metrics using digital portfolio tools Oversee operational processes and ensure adherence to quality and compliance standards Manage key vendor and service provider relationships in partnership with PPE, procurement and finance Support strategic planning and scenario analysis by integrating business needs with digital capabilities Lead change management efforts to drive adoption of digital tools and ways of working Provide executive reporting on digital progress and impact across R&D organization and the broader enterprise Provide leadership and governance for R&D digital architecture, ensuring consistency, scalability, interoperability, and alignment with enterprise IT frameworks and digital strategies Education & Requirements: 12+ years of experience in digital transformation, PMO, or portfolio management within R&D, biotech, or pharma Proven experience managing cross-functional digital programs or portfolios. Demonstrated success in managing cross-functional initiatives and complex program portfolios Strong operational and planning acumen, with knowledge of portfolio management tools (e.g., Planview, Smartsheet, Jira) Understanding of R&D processes and digital strategy trends in the life sciences sector Experience in digital architecture strategy, solution design, or enterprise architecture within R&D, with strong understanding of integration patterns, data flows, and platform scalability Experience with vendor and external partner governance Strong communication, change leadership, and executive reporting capabilities Our Benefits CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals. Please take the time to review our benefits site to see what's available to you as a CSL employee. About CSL Behring CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring . We want CSL to reflect the world around us At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. Learn more Inclusion and Belonging CSL . Do work that matters at CSL Behring!
The Position: The R&D Advanced Analytics, Automation, and AI Lead is responsible for executing the R&D digital acceleration roadmap, with a primary focus on delivering business value through advanced and emerging technologies. In close collaboration with I&T, this role oversees the design, development, and deployment of analytics, automation, and AI/ML solutions across the R&D value chain. The leader partners with RDLT, TES LT, I&T, and external innovation ecosystems to identify and apply disruptive technologies that enable measurable transformation. Acting as a strategic bridge between R&D and I&T, this role ensures digital acceleration initiatives are technically robust, operationally impactful, and fully aligned with enterprise architecture and capabilities. Responsibilities: Lead the development and execution of the R&D digital acceleration roadmap focused on automation, AI, and advanced analytics Identify disruptive technologies and use cases (e.g., generative AI, intelligent automation, simulation, digital twins) Partner with business stakeholders to develop scalable, production-ready digital solutions Lead agile teams to develop models, tools, and platforms aligned with R&D needs Drive rapid experimentation and innovation, ensuring feasibility, compliance, and user adoption Establish metrics to measure the impact of digital interventions on cycle times, quality, and outcomes Oversee partnerships with AI/ML vendors, academic collaborators, and industry consortia Build internal capabilities and talent pipelines for digital and analytics functions Ensure that all AI, automation, and advanced analytics solutions are implemented in a compliant manner, supporting readiness for regulatory audits and inspections involving emerging technologies Provide thought leadership in AI, including the development and implementation of AI governance frameworks, ethical AI practices, and active engagement with industry consortia such as Pistoia Alliance, CIOMS, TransCelerate, and other relevant forums to shape standards and best practices Education & Requirements: Master's or PhD in Data Science, Engineering, Computer Science, or related fields 15+ years of experience in digital leadership or advanced analytics/AI roles within R&D-driven pharmaceutical industry Deep knowledge of life sciences and experience applying AI/ML and automation in scientific or regulatory domains Demonstrated ability to deliver AI-enabled tools in regulated environments Strong cross-functional collaboration and change leadership skills Expertise in digital product lifecycle, from experimentation to scale Experience supporting regulatory audits and inspections involving emerging technologies, including AI and automation, in a GxP or highly regulated environment Our Benefits CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals. Please take the time to review our benefits site to see what's available to you as a CSL employee. About CSL Behring CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring . We want CSL to reflect the world around us At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. Learn more Inclusion and Belonging CSL . Do work that matters at CSL Behring!
Oct 04, 2025
Full time
The Position: The R&D Advanced Analytics, Automation, and AI Lead is responsible for executing the R&D digital acceleration roadmap, with a primary focus on delivering business value through advanced and emerging technologies. In close collaboration with I&T, this role oversees the design, development, and deployment of analytics, automation, and AI/ML solutions across the R&D value chain. The leader partners with RDLT, TES LT, I&T, and external innovation ecosystems to identify and apply disruptive technologies that enable measurable transformation. Acting as a strategic bridge between R&D and I&T, this role ensures digital acceleration initiatives are technically robust, operationally impactful, and fully aligned with enterprise architecture and capabilities. Responsibilities: Lead the development and execution of the R&D digital acceleration roadmap focused on automation, AI, and advanced analytics Identify disruptive technologies and use cases (e.g., generative AI, intelligent automation, simulation, digital twins) Partner with business stakeholders to develop scalable, production-ready digital solutions Lead agile teams to develop models, tools, and platforms aligned with R&D needs Drive rapid experimentation and innovation, ensuring feasibility, compliance, and user adoption Establish metrics to measure the impact of digital interventions on cycle times, quality, and outcomes Oversee partnerships with AI/ML vendors, academic collaborators, and industry consortia Build internal capabilities and talent pipelines for digital and analytics functions Ensure that all AI, automation, and advanced analytics solutions are implemented in a compliant manner, supporting readiness for regulatory audits and inspections involving emerging technologies Provide thought leadership in AI, including the development and implementation of AI governance frameworks, ethical AI practices, and active engagement with industry consortia such as Pistoia Alliance, CIOMS, TransCelerate, and other relevant forums to shape standards and best practices Education & Requirements: Master's or PhD in Data Science, Engineering, Computer Science, or related fields 15+ years of experience in digital leadership or advanced analytics/AI roles within R&D-driven pharmaceutical industry Deep knowledge of life sciences and experience applying AI/ML and automation in scientific or regulatory domains Demonstrated ability to deliver AI-enabled tools in regulated environments Strong cross-functional collaboration and change leadership skills Expertise in digital product lifecycle, from experimentation to scale Experience supporting regulatory audits and inspections involving emerging technologies, including AI and automation, in a GxP or highly regulated environment Our Benefits CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals. Please take the time to review our benefits site to see what's available to you as a CSL employee. About CSL Behring CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring . We want CSL to reflect the world around us At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. Learn more Inclusion and Belonging CSL . Do work that matters at CSL Behring!
The Position: The R&D Advanced Analytics, Automation, and AI Lead is responsible for executing the R&D digital acceleration roadmap, with a primary focus on delivering business value through advanced and emerging technologies. In close collaboration with I&T, this role oversees the design, development, and deployment of analytics, automation, and AI/ML solutions across the R&D value chain. The leader partners with RDLT, TES LT, I&T, and external innovation ecosystems to identify and apply disruptive technologies that enable measurable transformation. Acting as a strategic bridge between R&D and I&T, this role ensures digital acceleration initiatives are technically robust, operationally impactful, and fully aligned with enterprise architecture and capabilities. Responsibilities: Lead the development and execution of the R&D digital acceleration roadmap focused on automation, AI, and advanced analytics Identify disruptive technologies and use cases (e.g., generative AI, intelligent automation, simulation, digital twins) Partner with business stakeholders to develop scalable, production-ready digital solutions Lead agile teams to develop models, tools, and platforms aligned with R&D needs Drive rapid experimentation and innovation, ensuring feasibility, compliance, and user adoption Establish metrics to measure the impact of digital interventions on cycle times, quality, and outcomes Oversee partnerships with AI/ML vendors, academic collaborators, and industry consortia Build internal capabilities and talent pipelines for digital and analytics functions Ensure that all AI, automation, and advanced analytics solutions are implemented in a compliant manner, supporting readiness for regulatory audits and inspections involving emerging technologies Provide thought leadership in AI, including the development and implementation of AI governance frameworks, ethical AI practices, and active engagement with industry consortia such as Pistoia Alliance, CIOMS, TransCelerate, and other relevant forums to shape standards and best practices Education & Requirements: Master's or PhD in Data Science, Engineering, Computer Science, or related fields 15+ years of experience in digital leadership or advanced analytics/AI roles within R&D-driven pharmaceutical industry Deep knowledge of life sciences and experience applying AI/ML and automation in scientific or regulatory domains Demonstrated ability to deliver AI-enabled tools in regulated environments Strong cross-functional collaboration and change leadership skills Expertise in digital product lifecycle, from experimentation to scale Experience supporting regulatory audits and inspections involving emerging technologies, including AI and automation, in a GxP or highly regulated environment Our Benefits CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals. Please take the time to review our benefits site to see what's available to you as a CSL employee. About CSL Behring CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring . We want CSL to reflect the world around us At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. Learn more Inclusion and Belonging CSL . Do work that matters at CSL Behring!
Oct 04, 2025
Full time
The Position: The R&D Advanced Analytics, Automation, and AI Lead is responsible for executing the R&D digital acceleration roadmap, with a primary focus on delivering business value through advanced and emerging technologies. In close collaboration with I&T, this role oversees the design, development, and deployment of analytics, automation, and AI/ML solutions across the R&D value chain. The leader partners with RDLT, TES LT, I&T, and external innovation ecosystems to identify and apply disruptive technologies that enable measurable transformation. Acting as a strategic bridge between R&D and I&T, this role ensures digital acceleration initiatives are technically robust, operationally impactful, and fully aligned with enterprise architecture and capabilities. Responsibilities: Lead the development and execution of the R&D digital acceleration roadmap focused on automation, AI, and advanced analytics Identify disruptive technologies and use cases (e.g., generative AI, intelligent automation, simulation, digital twins) Partner with business stakeholders to develop scalable, production-ready digital solutions Lead agile teams to develop models, tools, and platforms aligned with R&D needs Drive rapid experimentation and innovation, ensuring feasibility, compliance, and user adoption Establish metrics to measure the impact of digital interventions on cycle times, quality, and outcomes Oversee partnerships with AI/ML vendors, academic collaborators, and industry consortia Build internal capabilities and talent pipelines for digital and analytics functions Ensure that all AI, automation, and advanced analytics solutions are implemented in a compliant manner, supporting readiness for regulatory audits and inspections involving emerging technologies Provide thought leadership in AI, including the development and implementation of AI governance frameworks, ethical AI practices, and active engagement with industry consortia such as Pistoia Alliance, CIOMS, TransCelerate, and other relevant forums to shape standards and best practices Education & Requirements: Master's or PhD in Data Science, Engineering, Computer Science, or related fields 15+ years of experience in digital leadership or advanced analytics/AI roles within R&D-driven pharmaceutical industry Deep knowledge of life sciences and experience applying AI/ML and automation in scientific or regulatory domains Demonstrated ability to deliver AI-enabled tools in regulated environments Strong cross-functional collaboration and change leadership skills Expertise in digital product lifecycle, from experimentation to scale Experience supporting regulatory audits and inspections involving emerging technologies, including AI and automation, in a GxP or highly regulated environment Our Benefits CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals. Please take the time to review our benefits site to see what's available to you as a CSL employee. About CSL Behring CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring . We want CSL to reflect the world around us At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. Learn more Inclusion and Belonging CSL . Do work that matters at CSL Behring!
CSL's R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration, we're building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide. The Head of Site Management and Monitoring is a senior leadership role accountable for the strategic direction, operational execution, and quality oversight of global site monitoring activities across all phases of clinical development. This role is pivotal in ensuring that clinical trial execution meets regulatory, ethical, and scientific standards while enabling operational excellence in a highly outsourced environment. Roles & Responsibilities Strategic Oversight and Quality Governance: Provide executive leadership in the development, execution, and continuous optimization of global oversight frameworks, including Monitoring Oversight Visits, Compliance Oversight Programs, and site-level risk mitigation strategies. Oversee GCP compliance and data integrity across a global footprint of more than 1,300 clinical trial sites and over 31,000 participants, ensuring alignment with enterprise risk and quality objectives. Operational Excellence in Monitoring: Drive strategic oversight of site management and monitoring activities across all phases of clinical development. Ensure global execution is fully aligned with protocol-specific risk assessments, regulatory requirements, and development timelines. Ensure the CRO(s) maintain high-quality, inspection-ready operations while proactively identifying and resolving site-level issues in a dynamic environment. CRO and FSP Governance: Lead governance of and oversight of Clinical Research Organization (CRO) partnerships. Act as a key strategic partner and influencer with CRO leadership, building strong relationships to drive accountability, resolve quality and performance issues-often on a daily basis given the operational scale-and ensure delivery to protocol and regulatory expectations. Cross-Functional Leadership and Regulatory Readiness: Partner with Clinical Operations, Quality Assurance, Regulatory Affairs, and CRO stakeholders to ensure global site performance, inspection readiness, and continuous improvement. Serve as the escalation lead for site-level quality and compliance issues, ensuring timely resolution, documentation, and alignment with regulatory standards and internal SOPs. Leadership and Capability Development: Lead a geographically dispersed team, fostering a culture of agility, accountability, and performance. Develop internal talent and oversee CRO capabilities to ensure consistent, high-quality oversight across a complex and evolving clinical operations landscape. Innovation and Risk-Based Monitoring Enablement: Champion the advancement of oversight technologies, dashboards, and analytics to support proactive, risk-based monitoring and data-driven decision-making. Drive innovation to meet the demands of large-scale, global clinical operations and deliver continual process optimization Qualifications & Experience Requirements Minimum undergraduate degree in life sciences or health/medical-related field; advanced degrees preferred. 12+ years of experience in clinical operations, with a strong background in site monitoring and vendor oversight. Proven leadership in managing global teams and implementing oversight strategies for site operations. Deep understanding of ICH-GCP, regulatory frameworks, and best practices in sponsor oversight. Strong analytical, communication, and stakeholder engagement skills Our Benefits We encourage you to make your well-being a priority. It's important and so are you. Learn more about how we care at CSL. About CSL Behring CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives. CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma . Our parent company, CSL , headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries. We want CSL to reflect the world around us At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. Learn more Inclusion and Belonging CSL Do work that matters at CSL Behring!
Oct 04, 2025
Full time
CSL's R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration, we're building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide. The Head of Site Management and Monitoring is a senior leadership role accountable for the strategic direction, operational execution, and quality oversight of global site monitoring activities across all phases of clinical development. This role is pivotal in ensuring that clinical trial execution meets regulatory, ethical, and scientific standards while enabling operational excellence in a highly outsourced environment. Roles & Responsibilities Strategic Oversight and Quality Governance: Provide executive leadership in the development, execution, and continuous optimization of global oversight frameworks, including Monitoring Oversight Visits, Compliance Oversight Programs, and site-level risk mitigation strategies. Oversee GCP compliance and data integrity across a global footprint of more than 1,300 clinical trial sites and over 31,000 participants, ensuring alignment with enterprise risk and quality objectives. Operational Excellence in Monitoring: Drive strategic oversight of site management and monitoring activities across all phases of clinical development. Ensure global execution is fully aligned with protocol-specific risk assessments, regulatory requirements, and development timelines. Ensure the CRO(s) maintain high-quality, inspection-ready operations while proactively identifying and resolving site-level issues in a dynamic environment. CRO and FSP Governance: Lead governance of and oversight of Clinical Research Organization (CRO) partnerships. Act as a key strategic partner and influencer with CRO leadership, building strong relationships to drive accountability, resolve quality and performance issues-often on a daily basis given the operational scale-and ensure delivery to protocol and regulatory expectations. Cross-Functional Leadership and Regulatory Readiness: Partner with Clinical Operations, Quality Assurance, Regulatory Affairs, and CRO stakeholders to ensure global site performance, inspection readiness, and continuous improvement. Serve as the escalation lead for site-level quality and compliance issues, ensuring timely resolution, documentation, and alignment with regulatory standards and internal SOPs. Leadership and Capability Development: Lead a geographically dispersed team, fostering a culture of agility, accountability, and performance. Develop internal talent and oversee CRO capabilities to ensure consistent, high-quality oversight across a complex and evolving clinical operations landscape. Innovation and Risk-Based Monitoring Enablement: Champion the advancement of oversight technologies, dashboards, and analytics to support proactive, risk-based monitoring and data-driven decision-making. Drive innovation to meet the demands of large-scale, global clinical operations and deliver continual process optimization Qualifications & Experience Requirements Minimum undergraduate degree in life sciences or health/medical-related field; advanced degrees preferred. 12+ years of experience in clinical operations, with a strong background in site monitoring and vendor oversight. Proven leadership in managing global teams and implementing oversight strategies for site operations. Deep understanding of ICH-GCP, regulatory frameworks, and best practices in sponsor oversight. Strong analytical, communication, and stakeholder engagement skills Our Benefits We encourage you to make your well-being a priority. It's important and so are you. Learn more about how we care at CSL. About CSL Behring CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives. CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma . Our parent company, CSL , headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries. We want CSL to reflect the world around us At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. Learn more Inclusion and Belonging CSL Do work that matters at CSL Behring!
CSL's R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration, we're building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide. Position Description Summary Responsible for leading the successful operational delivery of global, cross-functional R&D projects of strategic importance to CSL's product portfolio. Main Responsibilities & Accountabilities Work closely with project leader to define strategy and operational tactics Responsible for the preparation and management of project budgets, sensitivities, resources, project timelines, project scope and all other project documentation Accountable for the accuracy and quality of reports to senior stakeholders Lead cross functional development teams through tactical execution of project plans Identify, manage and resolve project issues and mitigate risks Ensure documentation of key team information, decisions, actions, modifications to scope, resources, timelines and milestones in project management systems is current. Identify, evaluate the critical path, scenarios and challenge assumptions to increase robustness of project plans Monitor performance vs. plan (budget and timeline) Coordinate program updates to Sr. Management Provide coaching and mentorship to more junior members of the R&D Global Project Management Department Qualifications & Experience Requirements Required: Bachelor degree or equivalent in Science, Engineering, or a related field. Preferred: An advanced degree (MSc, PhD) in Science or related field, Masters of Business Administration (MBA) or equivalent Project Management Professional (PMP) certification, 7+ years' experience in the biotechnology or pharmaceutical industry 5+ years' experience as a project manager leading cross-functional project teams in a matrixed, global environment, In-depth knowledge in drug research, development and manufacturing processes Demonstrated experience in delivering projects to meet business objectives on time, within budget and with quality Outstanding influencing ability & collaboration skills Proven success with building and developing matrix teams. Ability to work effectively in a matrix environment that includes interactions with multiple stakeholder groups Excellent executive presence, communication & change management skills. Exemplary project management skills Highly proficient in the use of Project Management processes and tools ( e.g. Microsoft Project) Our Benefits CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals. Please take the time to review our benefits site to see what's available to you as a CSL employee. About CSL Behring CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives. CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma . Our parent company, CSL , headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries. We want CSL to reflect the world around us At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. Learn more Inclusion and Belonging CSL . Do work that matters at CSL Behring!
Oct 02, 2025
Full time
CSL's R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration, we're building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide. Position Description Summary Responsible for leading the successful operational delivery of global, cross-functional R&D projects of strategic importance to CSL's product portfolio. Main Responsibilities & Accountabilities Work closely with project leader to define strategy and operational tactics Responsible for the preparation and management of project budgets, sensitivities, resources, project timelines, project scope and all other project documentation Accountable for the accuracy and quality of reports to senior stakeholders Lead cross functional development teams through tactical execution of project plans Identify, manage and resolve project issues and mitigate risks Ensure documentation of key team information, decisions, actions, modifications to scope, resources, timelines and milestones in project management systems is current. Identify, evaluate the critical path, scenarios and challenge assumptions to increase robustness of project plans Monitor performance vs. plan (budget and timeline) Coordinate program updates to Sr. Management Provide coaching and mentorship to more junior members of the R&D Global Project Management Department Qualifications & Experience Requirements Required: Bachelor degree or equivalent in Science, Engineering, or a related field. Preferred: An advanced degree (MSc, PhD) in Science or related field, Masters of Business Administration (MBA) or equivalent Project Management Professional (PMP) certification, 7+ years' experience in the biotechnology or pharmaceutical industry 5+ years' experience as a project manager leading cross-functional project teams in a matrixed, global environment, In-depth knowledge in drug research, development and manufacturing processes Demonstrated experience in delivering projects to meet business objectives on time, within budget and with quality Outstanding influencing ability & collaboration skills Proven success with building and developing matrix teams. Ability to work effectively in a matrix environment that includes interactions with multiple stakeholder groups Excellent executive presence, communication & change management skills. Exemplary project management skills Highly proficient in the use of Project Management processes and tools ( e.g. Microsoft Project) Our Benefits CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals. Please take the time to review our benefits site to see what's available to you as a CSL employee. About CSL Behring CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives. CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma . Our parent company, CSL , headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries. We want CSL to reflect the world around us At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. Learn more Inclusion and Belonging CSL . Do work that matters at CSL Behring!
The Position: The R&D Advanced Analytics, Automation, and AI Lead is responsible for executing the R&D digital acceleration roadmap, with a primary focus on delivering business value through advanced and emerging technologies. In close collaboration with I&T, this role oversees the design, development, and deployment of analytics, automation, and AI/ML solutions across the R&D value chain. The leader partners with RDLT, TES LT, I&T, and external innovation ecosystems to identify and apply disruptive technologies that enable measurable transformation. Acting as a strategic bridge between R&D and I&T, this role ensures digital acceleration initiatives are technically robust, operationally impactful, and fully aligned with enterprise architecture and capabilities. Responsibilities: Lead the development and execution of the R&D digital acceleration roadmap focused on automation, AI, and advanced analytics Identify disruptive technologies and use cases (e.g., generative AI, intelligent automation, simulation, digital twins) Partner with business stakeholders to develop scalable, production-ready digital solutions Lead agile teams to develop models, tools, and platforms aligned with R&D needs Drive rapid experimentation and innovation, ensuring feasibility, compliance, and user adoption Establish metrics to measure the impact of digital interventions on cycle times, quality, and outcomes Oversee partnerships with AI/ML vendors, academic collaborators, and industry consortia Build internal capabilities and talent pipelines for digital and analytics functions Ensure that all AI, automation, and advanced analytics solutions are implemented in a compliant manner, supporting readiness for regulatory audits and inspections involving emerging technologies Provide thought leadership in AI, including the development and implementation of AI governance frameworks, ethical AI practices, and active engagement with industry consortia such as Pistoia Alliance, CIOMS, TransCelerate, and other relevant forums to shape standards and best practices Education & Requirements: Master's or PhD in Data Science, Engineering, Computer Science, or related fields 15+ years of experience in digital leadership or advanced analytics/AI roles within R&D-driven pharmaceutical industry Deep knowledge of life sciences and experience applying AI/ML and automation in scientific or regulatory domains Demonstrated ability to deliver AI-enabled tools in regulated environments Strong cross-functional collaboration and change leadership skills Expertise in digital product lifecycle, from experimentation to scale Experience supporting regulatory audits and inspections involving emerging technologies, including AI and automation, in a GxP or highly regulated environment Our Benefits CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals. Please take the time to review our benefits site to see what's available to you as a CSL employee. About CSL Behring CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring . We want CSL to reflect the world around us At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. Learn more Inclusion and Belonging CSL . Do work that matters at CSL Behring!
Oct 02, 2025
Full time
The Position: The R&D Advanced Analytics, Automation, and AI Lead is responsible for executing the R&D digital acceleration roadmap, with a primary focus on delivering business value through advanced and emerging technologies. In close collaboration with I&T, this role oversees the design, development, and deployment of analytics, automation, and AI/ML solutions across the R&D value chain. The leader partners with RDLT, TES LT, I&T, and external innovation ecosystems to identify and apply disruptive technologies that enable measurable transformation. Acting as a strategic bridge between R&D and I&T, this role ensures digital acceleration initiatives are technically robust, operationally impactful, and fully aligned with enterprise architecture and capabilities. Responsibilities: Lead the development and execution of the R&D digital acceleration roadmap focused on automation, AI, and advanced analytics Identify disruptive technologies and use cases (e.g., generative AI, intelligent automation, simulation, digital twins) Partner with business stakeholders to develop scalable, production-ready digital solutions Lead agile teams to develop models, tools, and platforms aligned with R&D needs Drive rapid experimentation and innovation, ensuring feasibility, compliance, and user adoption Establish metrics to measure the impact of digital interventions on cycle times, quality, and outcomes Oversee partnerships with AI/ML vendors, academic collaborators, and industry consortia Build internal capabilities and talent pipelines for digital and analytics functions Ensure that all AI, automation, and advanced analytics solutions are implemented in a compliant manner, supporting readiness for regulatory audits and inspections involving emerging technologies Provide thought leadership in AI, including the development and implementation of AI governance frameworks, ethical AI practices, and active engagement with industry consortia such as Pistoia Alliance, CIOMS, TransCelerate, and other relevant forums to shape standards and best practices Education & Requirements: Master's or PhD in Data Science, Engineering, Computer Science, or related fields 15+ years of experience in digital leadership or advanced analytics/AI roles within R&D-driven pharmaceutical industry Deep knowledge of life sciences and experience applying AI/ML and automation in scientific or regulatory domains Demonstrated ability to deliver AI-enabled tools in regulated environments Strong cross-functional collaboration and change leadership skills Expertise in digital product lifecycle, from experimentation to scale Experience supporting regulatory audits and inspections involving emerging technologies, including AI and automation, in a GxP or highly regulated environment Our Benefits CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals. Please take the time to review our benefits site to see what's available to you as a CSL employee. About CSL Behring CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring . We want CSL to reflect the world around us At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. Learn more Inclusion and Belonging CSL . Do work that matters at CSL Behring!
The Position: The R&D Advanced Analytics, Automation, and AI Lead is responsible for executing the R&D digital acceleration roadmap, with a primary focus on delivering business value through advanced and emerging technologies. In close collaboration with I&T, this role oversees the design, development, and deployment of analytics, automation, and AI/ML solutions across the R&D value chain. The leader partners with RDLT, TES LT, I&T, and external innovation ecosystems to identify and apply disruptive technologies that enable measurable transformation. Acting as a strategic bridge between R&D and I&T, this role ensures digital acceleration initiatives are technically robust, operationally impactful, and fully aligned with enterprise architecture and capabilities. Responsibilities: Lead the development and execution of the R&D digital acceleration roadmap focused on automation, AI, and advanced analytics Identify disruptive technologies and use cases (e.g., generative AI, intelligent automation, simulation, digital twins) Partner with business stakeholders to develop scalable, production-ready digital solutions Lead agile teams to develop models, tools, and platforms aligned with R&D needs Drive rapid experimentation and innovation, ensuring feasibility, compliance, and user adoption Establish metrics to measure the impact of digital interventions on cycle times, quality, and outcomes Oversee partnerships with AI/ML vendors, academic collaborators, and industry consortia Build internal capabilities and talent pipelines for digital and analytics functions Ensure that all AI, automation, and advanced analytics solutions are implemented in a compliant manner, supporting readiness for regulatory audits and inspections involving emerging technologies Provide thought leadership in AI, including the development and implementation of AI governance frameworks, ethical AI practices, and active engagement with industry consortia such as Pistoia Alliance, CIOMS, TransCelerate, and other relevant forums to shape standards and best practices Education & Requirements: Master's or PhD in Data Science, Engineering, Computer Science, or related fields 15+ years of experience in digital leadership or advanced analytics/AI roles within R&D-driven pharmaceutical industry Deep knowledge of life sciences and experience applying AI/ML and automation in scientific or regulatory domains Demonstrated ability to deliver AI-enabled tools in regulated environments Strong cross-functional collaboration and change leadership skills Expertise in digital product lifecycle, from experimentation to scale Experience supporting regulatory audits and inspections involving emerging technologies, including AI and automation, in a GxP or highly regulated environment Our Benefits CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals. Please take the time to review our benefits site to see what's available to you as a CSL employee. About CSL Behring CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring . We want CSL to reflect the world around us At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. Learn more Inclusion and Belonging CSL . Do work that matters at CSL Behring!
Oct 02, 2025
Full time
The Position: The R&D Advanced Analytics, Automation, and AI Lead is responsible for executing the R&D digital acceleration roadmap, with a primary focus on delivering business value through advanced and emerging technologies. In close collaboration with I&T, this role oversees the design, development, and deployment of analytics, automation, and AI/ML solutions across the R&D value chain. The leader partners with RDLT, TES LT, I&T, and external innovation ecosystems to identify and apply disruptive technologies that enable measurable transformation. Acting as a strategic bridge between R&D and I&T, this role ensures digital acceleration initiatives are technically robust, operationally impactful, and fully aligned with enterprise architecture and capabilities. Responsibilities: Lead the development and execution of the R&D digital acceleration roadmap focused on automation, AI, and advanced analytics Identify disruptive technologies and use cases (e.g., generative AI, intelligent automation, simulation, digital twins) Partner with business stakeholders to develop scalable, production-ready digital solutions Lead agile teams to develop models, tools, and platforms aligned with R&D needs Drive rapid experimentation and innovation, ensuring feasibility, compliance, and user adoption Establish metrics to measure the impact of digital interventions on cycle times, quality, and outcomes Oversee partnerships with AI/ML vendors, academic collaborators, and industry consortia Build internal capabilities and talent pipelines for digital and analytics functions Ensure that all AI, automation, and advanced analytics solutions are implemented in a compliant manner, supporting readiness for regulatory audits and inspections involving emerging technologies Provide thought leadership in AI, including the development and implementation of AI governance frameworks, ethical AI practices, and active engagement with industry consortia such as Pistoia Alliance, CIOMS, TransCelerate, and other relevant forums to shape standards and best practices Education & Requirements: Master's or PhD in Data Science, Engineering, Computer Science, or related fields 15+ years of experience in digital leadership or advanced analytics/AI roles within R&D-driven pharmaceutical industry Deep knowledge of life sciences and experience applying AI/ML and automation in scientific or regulatory domains Demonstrated ability to deliver AI-enabled tools in regulated environments Strong cross-functional collaboration and change leadership skills Expertise in digital product lifecycle, from experimentation to scale Experience supporting regulatory audits and inspections involving emerging technologies, including AI and automation, in a GxP or highly regulated environment Our Benefits CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals. Please take the time to review our benefits site to see what's available to you as a CSL employee. About CSL Behring CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring . We want CSL to reflect the world around us At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. Learn more Inclusion and Belonging CSL . Do work that matters at CSL Behring!
The Position: The R&D Data Excellence Lead drives the vision, strategy, and execution of data excellence across the R&D organization. This role ensures that data is standardized, governed, and leveraged for advanced insights across scientific, clinical, safety, and regulatory domains. The role serves as a strategic advisor to R&D leadership, overseeing enterprise-aligned data infrastructure, data architecture, and standards to accelerate discovery, development, and decision-making. The role partners closely with enterprise I&T to ensure all data initiatives are scalable, compliant, and interoperable. Responsibilities: Define and execute the R&D-wide data and analytics strategy aligned to R&D 2.0 transformation goals and PD&C objectives Serve as a strategic advisor to R&D leadership on opportunities to improve pipeline productivity and operational efficiency using data Establish and govern data standards, metadata management, lineage, and ontologies across R&D domains Ensure compliance with enterprise data governance and facilitate its application across R&D data sets Partner with I&T to design and maintain scalable, secure, and interoperable data platforms Enable integration of diverse data types including clinical, real-world data, omics, imaging, and digital biomarkers Collaborate with Digital Business Partners and Analytics teams to ensure data readiness and accessibility for advanced analytics Foster cross-functional data alignment across clinical, safety, regulatory, and research domains Lead and develop a high-performing team of data stewards, scientists, and architects Engage external partners, consortia, and regulatory bodies to influence and align with industry data innovation Education & Requirements: Advanced degree (MS, PhD, or equivalent) in Data Science, Bioinformatics, Statistics, Computer Science, or a related field. 10+ years of data strategy and analytics experience in life sciences industry, with 5+ years in a leadership capacity. Strong knowledge of R&D processes, including discovery, translational, clinical development, and regulatory submissions Proven experience in enterprise data governance, architecture, and platform design in GxP environments. Familiarity with AI/ML enablement, though not focused on algorithm development. Strong stakeholder engagement, communication, and change leadership skills. Expertise with modern data stack: cloud platforms, data lakes, FAIR principles, and standards like CDISC, HL7/FHIR Our Benefits CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals. Please take the time to review our benefits site to see what's available to you as a CSL employee. About CSL Behring CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring . We want CSL to reflect the world around us At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. Learn more Inclusion and Belonging CSL . Do work that matters at CSL Behring!
Oct 01, 2025
Full time
The Position: The R&D Data Excellence Lead drives the vision, strategy, and execution of data excellence across the R&D organization. This role ensures that data is standardized, governed, and leveraged for advanced insights across scientific, clinical, safety, and regulatory domains. The role serves as a strategic advisor to R&D leadership, overseeing enterprise-aligned data infrastructure, data architecture, and standards to accelerate discovery, development, and decision-making. The role partners closely with enterprise I&T to ensure all data initiatives are scalable, compliant, and interoperable. Responsibilities: Define and execute the R&D-wide data and analytics strategy aligned to R&D 2.0 transformation goals and PD&C objectives Serve as a strategic advisor to R&D leadership on opportunities to improve pipeline productivity and operational efficiency using data Establish and govern data standards, metadata management, lineage, and ontologies across R&D domains Ensure compliance with enterprise data governance and facilitate its application across R&D data sets Partner with I&T to design and maintain scalable, secure, and interoperable data platforms Enable integration of diverse data types including clinical, real-world data, omics, imaging, and digital biomarkers Collaborate with Digital Business Partners and Analytics teams to ensure data readiness and accessibility for advanced analytics Foster cross-functional data alignment across clinical, safety, regulatory, and research domains Lead and develop a high-performing team of data stewards, scientists, and architects Engage external partners, consortia, and regulatory bodies to influence and align with industry data innovation Education & Requirements: Advanced degree (MS, PhD, or equivalent) in Data Science, Bioinformatics, Statistics, Computer Science, or a related field. 10+ years of data strategy and analytics experience in life sciences industry, with 5+ years in a leadership capacity. Strong knowledge of R&D processes, including discovery, translational, clinical development, and regulatory submissions Proven experience in enterprise data governance, architecture, and platform design in GxP environments. Familiarity with AI/ML enablement, though not focused on algorithm development. Strong stakeholder engagement, communication, and change leadership skills. Expertise with modern data stack: cloud platforms, data lakes, FAIR principles, and standards like CDISC, HL7/FHIR Our Benefits CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals. Please take the time to review our benefits site to see what's available to you as a CSL employee. About CSL Behring CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring . We want CSL to reflect the world around us At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. Learn more Inclusion and Belonging CSL . Do work that matters at CSL Behring!
The Position: The R&D Digital Strategy and Delivery Lead ensures that the digital portfolio across R&D is planned, executed, and tracked effectively to maximize business value. This role is responsible for governance, operational excellence, and strategic planning for TES initiatives, including program management, vendor oversight, and value realization tracking. The role partners with digital leaders, I&T, and finance to ensure disciplined delivery of the digital roadmap and portfolio transparency. This role will oversee the platform operations vendor relationship, as well as key R&D Technology Enabled Science vendor partnerships, in close collaboration with the PPE organization. The role also provides strategic oversight of R&D digital architecture to ensure scalable, integrated, and future-ready solutions aligned with enterprise technology standards. Responsibilities: Lead end-to-end portfolio management of R&D digital projects, ensuring alignment to R&D strategy and TES vision Manage governance structures, including steering committees and working groups, to oversee execution Monitor program performance, timelines, budgets, and ROI metrics using digital portfolio tools Oversee operational processes and ensure adherence to quality and compliance standards Manage key vendor and service provider relationships in partnership with PPE, procurement and finance Support strategic planning and scenario analysis by integrating business needs with digital capabilities Lead change management efforts to drive adoption of digital tools and ways of working Provide executive reporting on digital progress and impact across R&D organization and the broader enterprise Provide leadership and governance for R&D digital architecture, ensuring consistency, scalability, interoperability, and alignment with enterprise IT frameworks and digital strategies Education & Requirements: 12+ years of experience in digital transformation, PMO, or portfolio management within R&D, biotech, or pharma Proven experience managing cross-functional digital programs or portfolios. Demonstrated success in managing cross-functional initiatives and complex program portfolios Strong operational and planning acumen, with knowledge of portfolio management tools (e.g., Planview, Smartsheet, Jira) Understanding of R&D processes and digital strategy trends in the life sciences sector Experience in digital architecture strategy, solution design, or enterprise architecture within R&D, with strong understanding of integration patterns, data flows, and platform scalability Experience with vendor and external partner governance Strong communication, change leadership, and executive reporting capabilities Our Benefits CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals. Please take the time to review our benefits site to see what's available to you as a CSL employee. About CSL Behring CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring . We want CSL to reflect the world around us At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. Learn more Inclusion and Belonging CSL . Do work that matters at CSL Behring!
Oct 01, 2025
Full time
The Position: The R&D Digital Strategy and Delivery Lead ensures that the digital portfolio across R&D is planned, executed, and tracked effectively to maximize business value. This role is responsible for governance, operational excellence, and strategic planning for TES initiatives, including program management, vendor oversight, and value realization tracking. The role partners with digital leaders, I&T, and finance to ensure disciplined delivery of the digital roadmap and portfolio transparency. This role will oversee the platform operations vendor relationship, as well as key R&D Technology Enabled Science vendor partnerships, in close collaboration with the PPE organization. The role also provides strategic oversight of R&D digital architecture to ensure scalable, integrated, and future-ready solutions aligned with enterprise technology standards. Responsibilities: Lead end-to-end portfolio management of R&D digital projects, ensuring alignment to R&D strategy and TES vision Manage governance structures, including steering committees and working groups, to oversee execution Monitor program performance, timelines, budgets, and ROI metrics using digital portfolio tools Oversee operational processes and ensure adherence to quality and compliance standards Manage key vendor and service provider relationships in partnership with PPE, procurement and finance Support strategic planning and scenario analysis by integrating business needs with digital capabilities Lead change management efforts to drive adoption of digital tools and ways of working Provide executive reporting on digital progress and impact across R&D organization and the broader enterprise Provide leadership and governance for R&D digital architecture, ensuring consistency, scalability, interoperability, and alignment with enterprise IT frameworks and digital strategies Education & Requirements: 12+ years of experience in digital transformation, PMO, or portfolio management within R&D, biotech, or pharma Proven experience managing cross-functional digital programs or portfolios. Demonstrated success in managing cross-functional initiatives and complex program portfolios Strong operational and planning acumen, with knowledge of portfolio management tools (e.g., Planview, Smartsheet, Jira) Understanding of R&D processes and digital strategy trends in the life sciences sector Experience in digital architecture strategy, solution design, or enterprise architecture within R&D, with strong understanding of integration patterns, data flows, and platform scalability Experience with vendor and external partner governance Strong communication, change leadership, and executive reporting capabilities Our Benefits CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals. Please take the time to review our benefits site to see what's available to you as a CSL employee. About CSL Behring CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring . We want CSL to reflect the world around us At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. Learn more Inclusion and Belonging CSL . Do work that matters at CSL Behring!
CSL's R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration, we're building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide. The Head of Site Management and Monitoring is a senior leadership role accountable for the strategic direction, operational execution, and quality oversight of global site monitoring activities across all phases of clinical development. This role is pivotal in ensuring that clinical trial execution meets regulatory, ethical, and scientific standards while enabling operational excellence in a highly outsourced environment. Roles & Responsibilities Strategic Oversight and Quality Governance: Provide executive leadership in the development, execution, and continuous optimization of global oversight frameworks, including Monitoring Oversight Visits, Compliance Oversight Programs, and site-level risk mitigation strategies. Oversee GCP compliance and data integrity across a global footprint of more than 1,300 clinical trial sites and over 31,000 participants, ensuring alignment with enterprise risk and quality objectives. Operational Excellence in Monitoring: Drive strategic oversight of site management and monitoring activities across all phases of clinical development. Ensure global execution is fully aligned with protocol-specific risk assessments, regulatory requirements, and development timelines. Ensure the CRO(s) maintain high-quality, inspection-ready operations while proactively identifying and resolving site-level issues in a dynamic environment. CRO and FSP Governance: Lead governance of and oversight of Clinical Research Organization (CRO) partnerships. Act as a key strategic partner and influencer with CRO leadership, building strong relationships to drive accountability, resolve quality and performance issues-often on a daily basis given the operational scale-and ensure delivery to protocol and regulatory expectations. Cross-Functional Leadership and Regulatory Readiness: Partner with Clinical Operations, Quality Assurance, Regulatory Affairs, and CRO stakeholders to ensure global site performance, inspection readiness, and continuous improvement. Serve as the escalation lead for site-level quality and compliance issues, ensuring timely resolution, documentation, and alignment with regulatory standards and internal SOPs. Leadership and Capability Development: Lead a geographically dispersed team, fostering a culture of agility, accountability, and performance. Develop internal talent and oversee CRO capabilities to ensure consistent, high-quality oversight across a complex and evolving clinical operations landscape. Innovation and Risk-Based Monitoring Enablement: Champion the advancement of oversight technologies, dashboards, and analytics to support proactive, risk-based monitoring and data-driven decision-making. Drive innovation to meet the demands of large-scale, global clinical operations and deliver continual process optimization Qualifications & Experience Requirements Minimum undergraduate degree in life sciences or health/medical-related field; advanced degrees preferred. 12+ years of experience in clinical operations, with a strong background in site monitoring and vendor oversight. Proven leadership in managing global teams and implementing oversight strategies for site operations. Deep understanding of ICH-GCP, regulatory frameworks, and best practices in sponsor oversight. Strong analytical, communication, and stakeholder engagement skills Our Benefits We encourage you to make your well-being a priority. It's important and so are you. Learn more about how we care at CSL. About CSL Behring CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives. CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma . Our parent company, CSL , headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries. We want CSL to reflect the world around us At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. Learn more Inclusion and Belonging CSL Do work that matters at CSL Behring!
Oct 01, 2025
Full time
CSL's R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration, we're building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide. The Head of Site Management and Monitoring is a senior leadership role accountable for the strategic direction, operational execution, and quality oversight of global site monitoring activities across all phases of clinical development. This role is pivotal in ensuring that clinical trial execution meets regulatory, ethical, and scientific standards while enabling operational excellence in a highly outsourced environment. Roles & Responsibilities Strategic Oversight and Quality Governance: Provide executive leadership in the development, execution, and continuous optimization of global oversight frameworks, including Monitoring Oversight Visits, Compliance Oversight Programs, and site-level risk mitigation strategies. Oversee GCP compliance and data integrity across a global footprint of more than 1,300 clinical trial sites and over 31,000 participants, ensuring alignment with enterprise risk and quality objectives. Operational Excellence in Monitoring: Drive strategic oversight of site management and monitoring activities across all phases of clinical development. Ensure global execution is fully aligned with protocol-specific risk assessments, regulatory requirements, and development timelines. Ensure the CRO(s) maintain high-quality, inspection-ready operations while proactively identifying and resolving site-level issues in a dynamic environment. CRO and FSP Governance: Lead governance of and oversight of Clinical Research Organization (CRO) partnerships. Act as a key strategic partner and influencer with CRO leadership, building strong relationships to drive accountability, resolve quality and performance issues-often on a daily basis given the operational scale-and ensure delivery to protocol and regulatory expectations. Cross-Functional Leadership and Regulatory Readiness: Partner with Clinical Operations, Quality Assurance, Regulatory Affairs, and CRO stakeholders to ensure global site performance, inspection readiness, and continuous improvement. Serve as the escalation lead for site-level quality and compliance issues, ensuring timely resolution, documentation, and alignment with regulatory standards and internal SOPs. Leadership and Capability Development: Lead a geographically dispersed team, fostering a culture of agility, accountability, and performance. Develop internal talent and oversee CRO capabilities to ensure consistent, high-quality oversight across a complex and evolving clinical operations landscape. Innovation and Risk-Based Monitoring Enablement: Champion the advancement of oversight technologies, dashboards, and analytics to support proactive, risk-based monitoring and data-driven decision-making. Drive innovation to meet the demands of large-scale, global clinical operations and deliver continual process optimization Qualifications & Experience Requirements Minimum undergraduate degree in life sciences or health/medical-related field; advanced degrees preferred. 12+ years of experience in clinical operations, with a strong background in site monitoring and vendor oversight. Proven leadership in managing global teams and implementing oversight strategies for site operations. Deep understanding of ICH-GCP, regulatory frameworks, and best practices in sponsor oversight. Strong analytical, communication, and stakeholder engagement skills Our Benefits We encourage you to make your well-being a priority. It's important and so are you. Learn more about how we care at CSL. About CSL Behring CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives. CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma . Our parent company, CSL , headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries. We want CSL to reflect the world around us At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. Learn more Inclusion and Belonging CSL Do work that matters at CSL Behring!
CSL's R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration, we're building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide. Position Description Summary Responsible for leading the successful operational delivery of global, cross-functional R&D projects of strategic importance to CSL's product portfolio. Main Responsibilities & Accountabilities Work closely with project leader to define strategy and operational tactics Responsible for the preparation and management of project budgets, sensitivities, resources, project timelines, project scope and all other project documentation Accountable for the accuracy and quality of reports to senior stakeholders Lead cross functional development teams through tactical execution of project plans Identify, manage and resolve project issues and mitigate risks Ensure documentation of key team information, decisions, actions, modifications to scope, resources, timelines and milestones in project management systems is current. Identify, evaluate the critical path, scenarios and challenge assumptions to increase robustness of project plans Monitor performance vs. plan (budget and timeline) Coordinate program updates to Sr. Management Provide coaching and mentorship to more junior members of the R&D Global Project Management Department Qualifications & Experience Requirements Required: Bachelor degree or equivalent in Science, Engineering, or a related field. Preferred: An advanced degree (MSc, PhD) in Science or related field, Masters of Business Administration (MBA) or equivalent Project Management Professional (PMP) certification, 7+ years' experience in the biotechnology or pharmaceutical industry 5+ years' experience as a project manager leading cross-functional project teams in a matrixed, global environment, In-depth knowledge in drug research, development and manufacturing processes Demonstrated experience in delivering projects to meet business objectives on time, within budget and with quality Outstanding influencing ability & collaboration skills Proven success with building and developing matrix teams. Ability to work effectively in a matrix environment that includes interactions with multiple stakeholder groups Excellent executive presence, communication & change management skills. Exemplary project management skills Highly proficient in the use of Project Management processes and tools ( e.g. Microsoft Project) Our Benefits CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals. Please take the time to review our benefits site to see what's available to you as a CSL employee. About CSL Behring CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives. CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma . Our parent company, CSL , headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries. We want CSL to reflect the world around us At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. Learn more Inclusion and Belonging CSL . Do work that matters at CSL Behring!
Oct 01, 2025
Full time
CSL's R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration, we're building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide. Position Description Summary Responsible for leading the successful operational delivery of global, cross-functional R&D projects of strategic importance to CSL's product portfolio. Main Responsibilities & Accountabilities Work closely with project leader to define strategy and operational tactics Responsible for the preparation and management of project budgets, sensitivities, resources, project timelines, project scope and all other project documentation Accountable for the accuracy and quality of reports to senior stakeholders Lead cross functional development teams through tactical execution of project plans Identify, manage and resolve project issues and mitigate risks Ensure documentation of key team information, decisions, actions, modifications to scope, resources, timelines and milestones in project management systems is current. Identify, evaluate the critical path, scenarios and challenge assumptions to increase robustness of project plans Monitor performance vs. plan (budget and timeline) Coordinate program updates to Sr. Management Provide coaching and mentorship to more junior members of the R&D Global Project Management Department Qualifications & Experience Requirements Required: Bachelor degree or equivalent in Science, Engineering, or a related field. Preferred: An advanced degree (MSc, PhD) in Science or related field, Masters of Business Administration (MBA) or equivalent Project Management Professional (PMP) certification, 7+ years' experience in the biotechnology or pharmaceutical industry 5+ years' experience as a project manager leading cross-functional project teams in a matrixed, global environment, In-depth knowledge in drug research, development and manufacturing processes Demonstrated experience in delivering projects to meet business objectives on time, within budget and with quality Outstanding influencing ability & collaboration skills Proven success with building and developing matrix teams. Ability to work effectively in a matrix environment that includes interactions with multiple stakeholder groups Excellent executive presence, communication & change management skills. Exemplary project management skills Highly proficient in the use of Project Management processes and tools ( e.g. Microsoft Project) Our Benefits CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals. Please take the time to review our benefits site to see what's available to you as a CSL employee. About CSL Behring CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives. CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma . Our parent company, CSL , headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries. We want CSL to reflect the world around us At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. Learn more Inclusion and Belonging CSL . Do work that matters at CSL Behring!
The Position: The R&D Data Excellence Lead drives the vision, strategy, and execution of data excellence across the R&D organization. This role ensures that data is standardized, governed, and leveraged for advanced insights across scientific, clinical, safety, and regulatory domains. The role serves as a strategic advisor to R&D leadership, overseeing enterprise-aligned data infrastructure, data architecture, and standards to accelerate discovery, development, and decision-making. The role partners closely with enterprise I&T to ensure all data initiatives are scalable, compliant, and interoperable. Responsibilities: Define and execute the R&D-wide data and analytics strategy aligned to R&D 2.0 transformation goals and PD&C objectives Serve as a strategic advisor to R&D leadership on opportunities to improve pipeline productivity and operational efficiency using data Establish and govern data standards, metadata management, lineage, and ontologies across R&D domains Ensure compliance with enterprise data governance and facilitate its application across R&D data sets Partner with I&T to design and maintain scalable, secure, and interoperable data platforms Enable integration of diverse data types including clinical, real-world data, omics, imaging, and digital biomarkers Collaborate with Digital Business Partners and Analytics teams to ensure data readiness and accessibility for advanced analytics Foster cross-functional data alignment across clinical, safety, regulatory, and research domains Lead and develop a high-performing team of data stewards, scientists, and architects Engage external partners, consortia, and regulatory bodies to influence and align with industry data innovation Education & Requirements: Advanced degree (MS, PhD, or equivalent) in Data Science, Bioinformatics, Statistics, Computer Science, or a related field. 10+ years of data strategy and analytics experience in life sciences industry, with 5+ years in a leadership capacity. Strong knowledge of R&D processes, including discovery, translational, clinical development, and regulatory submissions Proven experience in enterprise data governance, architecture, and platform design in GxP environments. Familiarity with AI/ML enablement, though not focused on algorithm development. Strong stakeholder engagement, communication, and change leadership skills. Expertise with modern data stack: cloud platforms, data lakes, FAIR principles, and standards like CDISC, HL7/FHIR Our Benefits CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals. Please take the time to review our benefits site to see what's available to you as a CSL employee. About CSL Behring CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring . We want CSL to reflect the world around us At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. Learn more Inclusion and Belonging CSL . Do work that matters at CSL Behring!
Oct 01, 2025
Full time
The Position: The R&D Data Excellence Lead drives the vision, strategy, and execution of data excellence across the R&D organization. This role ensures that data is standardized, governed, and leveraged for advanced insights across scientific, clinical, safety, and regulatory domains. The role serves as a strategic advisor to R&D leadership, overseeing enterprise-aligned data infrastructure, data architecture, and standards to accelerate discovery, development, and decision-making. The role partners closely with enterprise I&T to ensure all data initiatives are scalable, compliant, and interoperable. Responsibilities: Define and execute the R&D-wide data and analytics strategy aligned to R&D 2.0 transformation goals and PD&C objectives Serve as a strategic advisor to R&D leadership on opportunities to improve pipeline productivity and operational efficiency using data Establish and govern data standards, metadata management, lineage, and ontologies across R&D domains Ensure compliance with enterprise data governance and facilitate its application across R&D data sets Partner with I&T to design and maintain scalable, secure, and interoperable data platforms Enable integration of diverse data types including clinical, real-world data, omics, imaging, and digital biomarkers Collaborate with Digital Business Partners and Analytics teams to ensure data readiness and accessibility for advanced analytics Foster cross-functional data alignment across clinical, safety, regulatory, and research domains Lead and develop a high-performing team of data stewards, scientists, and architects Engage external partners, consortia, and regulatory bodies to influence and align with industry data innovation Education & Requirements: Advanced degree (MS, PhD, or equivalent) in Data Science, Bioinformatics, Statistics, Computer Science, or a related field. 10+ years of data strategy and analytics experience in life sciences industry, with 5+ years in a leadership capacity. Strong knowledge of R&D processes, including discovery, translational, clinical development, and regulatory submissions Proven experience in enterprise data governance, architecture, and platform design in GxP environments. Familiarity with AI/ML enablement, though not focused on algorithm development. Strong stakeholder engagement, communication, and change leadership skills. Expertise with modern data stack: cloud platforms, data lakes, FAIR principles, and standards like CDISC, HL7/FHIR Our Benefits CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals. Please take the time to review our benefits site to see what's available to you as a CSL employee. About CSL Behring CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring . We want CSL to reflect the world around us At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. Learn more Inclusion and Belonging CSL . Do work that matters at CSL Behring!
The Position: The R&D Digital Strategy and Delivery Lead ensures that the digital portfolio across R&D is planned, executed, and tracked effectively to maximize business value. This role is responsible for governance, operational excellence, and strategic planning for TES initiatives, including program management, vendor oversight, and value realization tracking. The role partners with digital leaders, I&T, and finance to ensure disciplined delivery of the digital roadmap and portfolio transparency. This role will oversee the platform operations vendor relationship, as well as key R&D Technology Enabled Science vendor partnerships, in close collaboration with the PPE organization. The role also provides strategic oversight of R&D digital architecture to ensure scalable, integrated, and future-ready solutions aligned with enterprise technology standards. Responsibilities: Lead end-to-end portfolio management of R&D digital projects, ensuring alignment to R&D strategy and TES vision Manage governance structures, including steering committees and working groups, to oversee execution Monitor program performance, timelines, budgets, and ROI metrics using digital portfolio tools Oversee operational processes and ensure adherence to quality and compliance standards Manage key vendor and service provider relationships in partnership with PPE, procurement and finance Support strategic planning and scenario analysis by integrating business needs with digital capabilities Lead change management efforts to drive adoption of digital tools and ways of working Provide executive reporting on digital progress and impact across R&D organization and the broader enterprise Provide leadership and governance for R&D digital architecture, ensuring consistency, scalability, interoperability, and alignment with enterprise IT frameworks and digital strategies Education & Requirements: 12+ years of experience in digital transformation, PMO, or portfolio management within R&D, biotech, or pharma Proven experience managing cross-functional digital programs or portfolios. Demonstrated success in managing cross-functional initiatives and complex program portfolios Strong operational and planning acumen, with knowledge of portfolio management tools (e.g., Planview, Smartsheet, Jira) Understanding of R&D processes and digital strategy trends in the life sciences sector Experience in digital architecture strategy, solution design, or enterprise architecture within R&D, with strong understanding of integration patterns, data flows, and platform scalability Experience with vendor and external partner governance Strong communication, change leadership, and executive reporting capabilities Our Benefits CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals. Please take the time to review our benefits site to see what's available to you as a CSL employee. About CSL Behring CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring . We want CSL to reflect the world around us At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. Learn more Inclusion and Belonging CSL . Do work that matters at CSL Behring!
Oct 01, 2025
Full time
The Position: The R&D Digital Strategy and Delivery Lead ensures that the digital portfolio across R&D is planned, executed, and tracked effectively to maximize business value. This role is responsible for governance, operational excellence, and strategic planning for TES initiatives, including program management, vendor oversight, and value realization tracking. The role partners with digital leaders, I&T, and finance to ensure disciplined delivery of the digital roadmap and portfolio transparency. This role will oversee the platform operations vendor relationship, as well as key R&D Technology Enabled Science vendor partnerships, in close collaboration with the PPE organization. The role also provides strategic oversight of R&D digital architecture to ensure scalable, integrated, and future-ready solutions aligned with enterprise technology standards. Responsibilities: Lead end-to-end portfolio management of R&D digital projects, ensuring alignment to R&D strategy and TES vision Manage governance structures, including steering committees and working groups, to oversee execution Monitor program performance, timelines, budgets, and ROI metrics using digital portfolio tools Oversee operational processes and ensure adherence to quality and compliance standards Manage key vendor and service provider relationships in partnership with PPE, procurement and finance Support strategic planning and scenario analysis by integrating business needs with digital capabilities Lead change management efforts to drive adoption of digital tools and ways of working Provide executive reporting on digital progress and impact across R&D organization and the broader enterprise Provide leadership and governance for R&D digital architecture, ensuring consistency, scalability, interoperability, and alignment with enterprise IT frameworks and digital strategies Education & Requirements: 12+ years of experience in digital transformation, PMO, or portfolio management within R&D, biotech, or pharma Proven experience managing cross-functional digital programs or portfolios. Demonstrated success in managing cross-functional initiatives and complex program portfolios Strong operational and planning acumen, with knowledge of portfolio management tools (e.g., Planview, Smartsheet, Jira) Understanding of R&D processes and digital strategy trends in the life sciences sector Experience in digital architecture strategy, solution design, or enterprise architecture within R&D, with strong understanding of integration patterns, data flows, and platform scalability Experience with vendor and external partner governance Strong communication, change leadership, and executive reporting capabilities Our Benefits CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals. Please take the time to review our benefits site to see what's available to you as a CSL employee. About CSL Behring CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring . We want CSL to reflect the world around us At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. Learn more Inclusion and Belonging CSL . Do work that matters at CSL Behring!
CSL's R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration, we're building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide. Position Description Summary Responsible for leading the successful operational delivery of global, cross-functional R&D projects of strategic importance to CSL's product portfolio. Main Responsibilities & Accountabilities Work closely with project leader to define strategy and operational tactics Responsible for the preparation and management of project budgets, sensitivities, resources, project timelines, project scope and all other project documentation Accountable for the accuracy and quality of reports to senior stakeholders Lead cross functional development teams through tactical execution of project plans Identify, manage and resolve project issues and mitigate risks Ensure documentation of key team information, decisions, actions, modifications to scope, resources, timelines and milestones in project management systems is current. Identify, evaluate the critical path, scenarios and challenge assumptions to increase robustness of project plans Monitor performance vs. plan (budget and timeline) Coordinate program updates to Sr. Management Provide coaching and mentorship to more junior members of the R&D Global Project Management Department Qualifications & Experience Requirements Required: Bachelor degree or equivalent in Science, Engineering, or a related field. Preferred: An advanced degree (MSc, PhD) in Science or related field, Masters of Business Administration (MBA) or equivalent Project Management Professional (PMP) certification, 7+ years' experience in the biotechnology or pharmaceutical industry 5+ years' experience as a project manager leading cross-functional project teams in a matrixed, global environment, In-depth knowledge in drug research, development and manufacturing processes Demonstrated experience in delivering projects to meet business objectives on time, within budget and with quality Outstanding influencing ability & collaboration skills Proven success with building and developing matrix teams. Ability to work effectively in a matrix environment that includes interactions with multiple stakeholder groups Excellent executive presence, communication & change management skills. Exemplary project management skills Highly proficient in the use of Project Management processes and tools ( e.g. Microsoft Project) Our Benefits CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals. Please take the time to review our benefits site to see what's available to you as a CSL employee. About CSL Behring CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives. CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma . Our parent company, CSL , headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries. We want CSL to reflect the world around us At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. Learn more Inclusion and Belonging CSL . Do work that matters at CSL Behring!
Oct 01, 2025
Full time
CSL's R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration, we're building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide. Position Description Summary Responsible for leading the successful operational delivery of global, cross-functional R&D projects of strategic importance to CSL's product portfolio. Main Responsibilities & Accountabilities Work closely with project leader to define strategy and operational tactics Responsible for the preparation and management of project budgets, sensitivities, resources, project timelines, project scope and all other project documentation Accountable for the accuracy and quality of reports to senior stakeholders Lead cross functional development teams through tactical execution of project plans Identify, manage and resolve project issues and mitigate risks Ensure documentation of key team information, decisions, actions, modifications to scope, resources, timelines and milestones in project management systems is current. Identify, evaluate the critical path, scenarios and challenge assumptions to increase robustness of project plans Monitor performance vs. plan (budget and timeline) Coordinate program updates to Sr. Management Provide coaching and mentorship to more junior members of the R&D Global Project Management Department Qualifications & Experience Requirements Required: Bachelor degree or equivalent in Science, Engineering, or a related field. Preferred: An advanced degree (MSc, PhD) in Science or related field, Masters of Business Administration (MBA) or equivalent Project Management Professional (PMP) certification, 7+ years' experience in the biotechnology or pharmaceutical industry 5+ years' experience as a project manager leading cross-functional project teams in a matrixed, global environment, In-depth knowledge in drug research, development and manufacturing processes Demonstrated experience in delivering projects to meet business objectives on time, within budget and with quality Outstanding influencing ability & collaboration skills Proven success with building and developing matrix teams. Ability to work effectively in a matrix environment that includes interactions with multiple stakeholder groups Excellent executive presence, communication & change management skills. Exemplary project management skills Highly proficient in the use of Project Management processes and tools ( e.g. Microsoft Project) Our Benefits CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals. Please take the time to review our benefits site to see what's available to you as a CSL employee. About CSL Behring CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives. CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma . Our parent company, CSL , headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries. We want CSL to reflect the world around us At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. Learn more Inclusion and Belonging CSL . Do work that matters at CSL Behring!
CSL's R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration, we're building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide. The Head of Site Management and Monitoring is a senior leadership role accountable for the strategic direction, operational execution, and quality oversight of global site monitoring activities across all phases of clinical development. This role is pivotal in ensuring that clinical trial execution meets regulatory, ethical, and scientific standards while enabling operational excellence in a highly outsourced environment. Roles & Responsibilities Strategic Oversight and Quality Governance: Provide executive leadership in the development, execution, and continuous optimization of global oversight frameworks, including Monitoring Oversight Visits, Compliance Oversight Programs, and site-level risk mitigation strategies. Oversee GCP compliance and data integrity across a global footprint of more than 1,300 clinical trial sites and over 31,000 participants, ensuring alignment with enterprise risk and quality objectives. Operational Excellence in Monitoring: Drive strategic oversight of site management and monitoring activities across all phases of clinical development. Ensure global execution is fully aligned with protocol-specific risk assessments, regulatory requirements, and development timelines. Ensure the CRO(s) maintain high-quality, inspection-ready operations while proactively identifying and resolving site-level issues in a dynamic environment. CRO and FSP Governance: Lead governance of and oversight of Clinical Research Organization (CRO) partnerships. Act as a key strategic partner and influencer with CRO leadership, building strong relationships to drive accountability, resolve quality and performance issues-often on a daily basis given the operational scale-and ensure delivery to protocol and regulatory expectations. Cross-Functional Leadership and Regulatory Readiness: Partner with Clinical Operations, Quality Assurance, Regulatory Affairs, and CRO stakeholders to ensure global site performance, inspection readiness, and continuous improvement. Serve as the escalation lead for site-level quality and compliance issues, ensuring timely resolution, documentation, and alignment with regulatory standards and internal SOPs. Leadership and Capability Development: Lead a geographically dispersed team, fostering a culture of agility, accountability, and performance. Develop internal talent and oversee CRO capabilities to ensure consistent, high-quality oversight across a complex and evolving clinical operations landscape. Innovation and Risk-Based Monitoring Enablement: Champion the advancement of oversight technologies, dashboards, and analytics to support proactive, risk-based monitoring and data-driven decision-making. Drive innovation to meet the demands of large-scale, global clinical operations and deliver continual process optimization Qualifications & Experience Requirements Minimum undergraduate degree in life sciences or health/medical-related field; advanced degrees preferred. 12+ years of experience in clinical operations, with a strong background in site monitoring and vendor oversight. Proven leadership in managing global teams and implementing oversight strategies for site operations. Deep understanding of ICH-GCP, regulatory frameworks, and best practices in sponsor oversight. Strong analytical, communication, and stakeholder engagement skills Our Benefits We encourage you to make your well-being a priority. It's important and so are you. Learn more about how we care at CSL. About CSL Behring CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives. CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma . Our parent company, CSL , headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries. We want CSL to reflect the world around us At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. Learn more Inclusion and Belonging CSL Do work that matters at CSL Behring!
Oct 01, 2025
Full time
CSL's R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration, we're building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide. The Head of Site Management and Monitoring is a senior leadership role accountable for the strategic direction, operational execution, and quality oversight of global site monitoring activities across all phases of clinical development. This role is pivotal in ensuring that clinical trial execution meets regulatory, ethical, and scientific standards while enabling operational excellence in a highly outsourced environment. Roles & Responsibilities Strategic Oversight and Quality Governance: Provide executive leadership in the development, execution, and continuous optimization of global oversight frameworks, including Monitoring Oversight Visits, Compliance Oversight Programs, and site-level risk mitigation strategies. Oversee GCP compliance and data integrity across a global footprint of more than 1,300 clinical trial sites and over 31,000 participants, ensuring alignment with enterprise risk and quality objectives. Operational Excellence in Monitoring: Drive strategic oversight of site management and monitoring activities across all phases of clinical development. Ensure global execution is fully aligned with protocol-specific risk assessments, regulatory requirements, and development timelines. Ensure the CRO(s) maintain high-quality, inspection-ready operations while proactively identifying and resolving site-level issues in a dynamic environment. CRO and FSP Governance: Lead governance of and oversight of Clinical Research Organization (CRO) partnerships. Act as a key strategic partner and influencer with CRO leadership, building strong relationships to drive accountability, resolve quality and performance issues-often on a daily basis given the operational scale-and ensure delivery to protocol and regulatory expectations. Cross-Functional Leadership and Regulatory Readiness: Partner with Clinical Operations, Quality Assurance, Regulatory Affairs, and CRO stakeholders to ensure global site performance, inspection readiness, and continuous improvement. Serve as the escalation lead for site-level quality and compliance issues, ensuring timely resolution, documentation, and alignment with regulatory standards and internal SOPs. Leadership and Capability Development: Lead a geographically dispersed team, fostering a culture of agility, accountability, and performance. Develop internal talent and oversee CRO capabilities to ensure consistent, high-quality oversight across a complex and evolving clinical operations landscape. Innovation and Risk-Based Monitoring Enablement: Champion the advancement of oversight technologies, dashboards, and analytics to support proactive, risk-based monitoring and data-driven decision-making. Drive innovation to meet the demands of large-scale, global clinical operations and deliver continual process optimization Qualifications & Experience Requirements Minimum undergraduate degree in life sciences or health/medical-related field; advanced degrees preferred. 12+ years of experience in clinical operations, with a strong background in site monitoring and vendor oversight. Proven leadership in managing global teams and implementing oversight strategies for site operations. Deep understanding of ICH-GCP, regulatory frameworks, and best practices in sponsor oversight. Strong analytical, communication, and stakeholder engagement skills Our Benefits We encourage you to make your well-being a priority. It's important and so are you. Learn more about how we care at CSL. About CSL Behring CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives. CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma . Our parent company, CSL , headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries. We want CSL to reflect the world around us At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. Learn more Inclusion and Belonging CSL Do work that matters at CSL Behring!
CSL's R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration, were building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide click apply for full job details
Sep 28, 2025
Full time
CSL's R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration, were building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide click apply for full job details
This position is responsible for providing technical leadership within the process engineering department for equipment and process design for Seqirus Liverpools products ensuring the engineering solutions meet cost, reliability, schedule, and performance integrity requirements. Additionally, this position is responsible for the planning and execution of all process engineering activities from pre click apply for full job details
Sep 26, 2025
Full time
This position is responsible for providing technical leadership within the process engineering department for equipment and process design for Seqirus Liverpools products ensuring the engineering solutions meet cost, reliability, schedule, and performance integrity requirements. Additionally, this position is responsible for the planning and execution of all process engineering activities from pre click apply for full job details