Simbec Orion Group
Our Mission Our passion for improving patients' lives motivates us to apply our skills, experience and knowledge to advance medicine. We achieve this through flexible, innovative, high quality solutions for our clients, delivered with integrity. The Role We are seeking a Medical Director to join our Clinical Development team, providing senior medical oversight for complex clinical studies conducted by Simbec Orion. You will be responsible for ensuring scientific integrity, patient safety, and regulatory compliance throughout the study lifecycle, while acting as Medical Monitor for assigned trials and delivering expert clinical interpretation and safety leadership. You will work cross functionally with teams including Clinical Operations, Project Management, Pharmacovigilance, Biometrics, Regulatory, Technical Writing, and Business Development to support high quality study delivery and consistent medical standards across the organisation. In addition, you will contribute strategic medical expertise to proposals, feasibility assessments, and study design, and represent the medical function in client discussions and bid defence meetings, clearly articulating clinical strategy and safety oversight to support successful business development outcomes. Key Accountabilities Act as Medical Monitor for assigned clinical trials, providing independent medical oversight throughout the study lifecycle. Serve as the primary escalation point for internal and external stakeholders for all medical and safety issues within assigned studies. Ensure clinical trials are conducted in compliance with applicable regulations, guidelines, and ethical standards. Collaborate cross functionally to support successful study delivery and maintain high levels of client satisfaction. Oversee the preparation and review of medical and patient narratives and safety update reports to ensure accuracy, quality, and regulatory compliance. Ensure departmental SOPs are reviewed regularly and updated in line with current regulations, guidelines, and industry best practice. Contribute to all stages of clinical trial development, including feasibility assessment, protocol and case report form design, investigational site selection, medical monitoring plan development, ongoing medical oversight, adverse event and serious adverse event management, and participation in study related meetings. Support business development activities, including proposals, feasibility assessments, site engagement, and bid defence meetings. Provide therapeutic area expertise across the organisation, including delivery of internal training and review of study protocols and bid proposals. Lead the resolution of departmental CAPAs and escalations, and cascade relevant audit findings to study teams to ensure appropriate corrective and preventive action. Ensure timely and comprehensive responses to audit findings and regulatory queries relating to medical and safety matters. Maintain up to date knowledge of developments in therapeutic areas, regulatory requirements, and medical practice relevant to company projects. Develop and maintain relationships with Key Opinion Leaders and investigators to support study design, patient safety assessment, and business development activities. Support the Pharmacovigilance function through medical review of ICs, CIOMS narratives, and periodic safety reports, identifying and communicating emerging safety trends to project teams and clients. Provide effective line management to assigned team members, including performance management, objective setting, resource planning, professional development, and ensuring delivery of high quality work aligned with regulatory, organisational, and study requirements. Skills Required ESSENTIAL Medical degree with specialisation in Oncology (or equivalent clinical experience in oncology) Substantial experience as a Medical Monitor within a clinical research environment, with a focus on oncology studies and patient safety oversight Extensive experience in clinical trial medical oversight within oncology, including adverse event and serious adverse event management, safety signal evaluation, and regulatory compliance Experience supporting regulatory inspections and audits, including CAPA development and management Demonstrable involvement in business development activities, including feasibility assessments, protocol input, proposal development, and bid defence participation within oncology trials Strong commercial awareness, including understanding of clinical trial budgeting and financial drivers within a CRO environment Strong written and verbal communication skills, with the ability to translate complex oncology data into clear insights for clients and cross functional teams Proficiency in electronic data capture systems, safety databases, and Microsoft Office applications DESIRABLE GMC registered with a licence to practise (or equivalent international registration) with oncology specialism Pharmacovigilance experience within oncology, including medical review of ICs and periodic safety reports Experience working within a CRO, biotechnology, or pharmaceutical environment with a focus on oncology drug development Previous experience leading a medical and/or safety function, including direct line management responsibility About Us Simbec Orion is a responsive and agile full service CRO, delivering studies from first in man through to Phase III. Our experts leverage wide therapeutic experience and specialist expertise to execute a comprehensive portfolio of trials. We are perfectly structured to provide full service clinical development solutions for small and mid size drug developers, headed up by a centralised leadership team. With a focus on tailormade and scalable solutions, we adapt our delivery style, communications and operations to suit the demands of the project, helping clients achieve their clinical and commercial objectives. Because our goal is the same as theirs; to improve patients' lives.
Our Mission Our passion for improving patients' lives motivates us to apply our skills, experience and knowledge to advance medicine. We achieve this through flexible, innovative, high quality solutions for our clients, delivered with integrity. The Role We are seeking a Medical Director to join our Clinical Development team, providing senior medical oversight for complex clinical studies conducted by Simbec Orion. You will be responsible for ensuring scientific integrity, patient safety, and regulatory compliance throughout the study lifecycle, while acting as Medical Monitor for assigned trials and delivering expert clinical interpretation and safety leadership. You will work cross functionally with teams including Clinical Operations, Project Management, Pharmacovigilance, Biometrics, Regulatory, Technical Writing, and Business Development to support high quality study delivery and consistent medical standards across the organisation. In addition, you will contribute strategic medical expertise to proposals, feasibility assessments, and study design, and represent the medical function in client discussions and bid defence meetings, clearly articulating clinical strategy and safety oversight to support successful business development outcomes. Key Accountabilities Act as Medical Monitor for assigned clinical trials, providing independent medical oversight throughout the study lifecycle. Serve as the primary escalation point for internal and external stakeholders for all medical and safety issues within assigned studies. Ensure clinical trials are conducted in compliance with applicable regulations, guidelines, and ethical standards. Collaborate cross functionally to support successful study delivery and maintain high levels of client satisfaction. Oversee the preparation and review of medical and patient narratives and safety update reports to ensure accuracy, quality, and regulatory compliance. Ensure departmental SOPs are reviewed regularly and updated in line with current regulations, guidelines, and industry best practice. Contribute to all stages of clinical trial development, including feasibility assessment, protocol and case report form design, investigational site selection, medical monitoring plan development, ongoing medical oversight, adverse event and serious adverse event management, and participation in study related meetings. Support business development activities, including proposals, feasibility assessments, site engagement, and bid defence meetings. Provide therapeutic area expertise across the organisation, including delivery of internal training and review of study protocols and bid proposals. Lead the resolution of departmental CAPAs and escalations, and cascade relevant audit findings to study teams to ensure appropriate corrective and preventive action. Ensure timely and comprehensive responses to audit findings and regulatory queries relating to medical and safety matters. Maintain up to date knowledge of developments in therapeutic areas, regulatory requirements, and medical practice relevant to company projects. Develop and maintain relationships with Key Opinion Leaders and investigators to support study design, patient safety assessment, and business development activities. Support the Pharmacovigilance function through medical review of ICs, CIOMS narratives, and periodic safety reports, identifying and communicating emerging safety trends to project teams and clients. Provide effective line management to assigned team members, including performance management, objective setting, resource planning, professional development, and ensuring delivery of high quality work aligned with regulatory, organisational, and study requirements. Skills Required ESSENTIAL Medical degree with specialisation in Oncology (or equivalent clinical experience in oncology) Substantial experience as a Medical Monitor within a clinical research environment, with a focus on oncology studies and patient safety oversight Extensive experience in clinical trial medical oversight within oncology, including adverse event and serious adverse event management, safety signal evaluation, and regulatory compliance Experience supporting regulatory inspections and audits, including CAPA development and management Demonstrable involvement in business development activities, including feasibility assessments, protocol input, proposal development, and bid defence participation within oncology trials Strong commercial awareness, including understanding of clinical trial budgeting and financial drivers within a CRO environment Strong written and verbal communication skills, with the ability to translate complex oncology data into clear insights for clients and cross functional teams Proficiency in electronic data capture systems, safety databases, and Microsoft Office applications DESIRABLE GMC registered with a licence to practise (or equivalent international registration) with oncology specialism Pharmacovigilance experience within oncology, including medical review of ICs and periodic safety reports Experience working within a CRO, biotechnology, or pharmaceutical environment with a focus on oncology drug development Previous experience leading a medical and/or safety function, including direct line management responsibility About Us Simbec Orion is a responsive and agile full service CRO, delivering studies from first in man through to Phase III. Our experts leverage wide therapeutic experience and specialist expertise to execute a comprehensive portfolio of trials. We are perfectly structured to provide full service clinical development solutions for small and mid size drug developers, headed up by a centralised leadership team. With a focus on tailormade and scalable solutions, we adapt our delivery style, communications and operations to suit the demands of the project, helping clients achieve their clinical and commercial objectives. Because our goal is the same as theirs; to improve patients' lives.