Associate Director, Clinical Trial Disclosure & Transparency

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.

We are seking an Associate Director Clinical Trial Disclosure and Transparency is a global subject matter expert responsible for ensuring timely, accurate, and compliant clinical trial disclosures across all regions and study types (interventional and observational). This role guides global strategy, drives process excellence, and oversees the delivery of registration, results,andlayperson summaries,anonymization and redaction of commercially confidential information (CCI)for clinical trials, inalignment with international regulations, CSL policy and industry standardsand transparency requirements.

Key Responsibilities

Strategic Oversight & Compliance
Lead enterpriseclinical trialdisclosure andtransparencystrategy and advise therapeutic areas and Medical Affairs on global requirements (e.g., FDAAA 801and the Final Rule,clinicaltrials.gov, CTIS,EU CTR 536/2014,EMA Policy 70, Health Canada PRCI)
Develop and implement scalable, efficient processes that meet evolving regulatory and industry standards
Serve as the primary liaison to public registries (e.g., ClinicalTrials.gov, EudraCT, EU PAS).
Disclosure Execution
Oversee and deliver high-quality, compliant disclosures including study registration, protocol amendments, summary results, and lay-person summaries
Ensure timely communication of disclosure obligations to clinical teams, affiliates, and stakeholders
Support CROs and local teams with regional disclosure needs

Transparency Execution

Oversee and deliver high-quality, compliant redacted document packages for public release by global Health Authorities

Advise on transparency obligations and best practices, including promotion of Smart Authoring practices, to clinical teams and functions
Cross Functional Engagement
Partner with Clinical Development, Biostats, Medical Writing, Regulatory,IP, Legal,Data Privacyand CMO staff to embed disclosureand transparencyrequirements across the development lifecycle
Represent CSLs disclosureand transparencypractices internally and externally, ensuring alignment with global standards and expectations
Vendor Management
Select, manage, and oversee disclosureand transparencyvendors to ensure high-quality deliverables and on-time execution
Optimize resourcing and technology to support cost-effective delivery
Metrics & Monitoring
Track and report key metrics to demonstrate compliance and process performance

Skills and Experience Required

10+ years in pharmaceutical/biotech environment with deep knowledge of the drug development process

Expert in global clinical trial disclosureand transparencyregulations,andguidelines and registries

Proven track record in managing global disclosureand transparencydeliverables and working in cross-functional, matrixed teams

Strong understanding of ICH-GCP, ICMJE,GDPRand industry best practices

Experience with vendor oversight, process improvement, and innovation indisclosure andtransparency operations andtransparencyexecution

Hands onexperiencewith the use and administrationof theinTrialscope Disclose system(or equivalent)

Qualifications and Education Required

Bachelors degree in a scientific, medical, or pharmaceutical discipline required

We encourage you to make your well-being a priority. Its important and so are you. Learn more about how we care at CSL.

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 worlds 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.

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

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