Clinical Trial Physician, Cell Therapy, Medical Evidence Generation

This Director, Medical Evidence Generation (MEG) Clinical Trial Physician (CTP) - Cell Therapy (CT) role in Medical Affairs manages the evidence generation for the CT portfolio (including Medical Affairs Sponsored studies [MAST]) and provides clinical support for other studies in the MEG book of work (BOW).  In this role, he/she will serve as the primary source of medical/clinical accountability and oversight for a MAST in alignment with the Integrated Evidence Plans (IEP) for the assets in Cell Therapy portfolio. He/she will work closely with Worldwide Medical (WWM) Cell Therapy Asset Lead, the MEG Cell Therapy Lead, and other members of the study team for the day-to-day oversight and conduction of the clinical studies included in the BOW for an asset in the Cell Therapy portfolio. The CT MEG CTP will lead and participate in cross-functional matrix leadership teams focused on building these relationships and actively sourcing research concepts that address critical evidence gaps for early and late assets being developed in prioritized indications.

This role will report to the Cell Therapy MEG Lead and will be expected to:

• Provide medical/clinical accountability and oversight for the various medical affairs-led sponsored studies (interventional and non-interventional), in alignment with the Integrated Evidence Plans (IEP) for the assets in company’s portfolio.
• Collaborate with the TA Medical Lead, CT MEG Lead, Clinical Scientist (CS), and Global Trial Manager (GTM) for the development of the study protocol and ICF, authoring and providing medical input during protocol development.
• Partner with Clinical Scientist (CS) and Global Trial Manager (GTM) to support executional delivery of studies (e.g., clinical database development, clinical data oversight, site activation, enrollment status, as well as adjudication for protocol violations, significant, non-significant deviations etc.).
• Hold responsibility for assessment of key safety-related serious adverse events in partnership with Worldwide Patient Safety and oversees safety narratives (if applicable).
• Accountable for medical data review of trial data, including eligibility assessment and interpretation of trial data results.
• Provide medical oversight and accountability for the study-related work conducted by external partners (CROs), particularly related to medical monitoring-related activities.
• Provide continuous medical education in partnership with CTLs and T/A Medical Leads related to protocol-specific training (supporting the study team, investigators, CROs, and others).
• Provide medical expertise during Study Steering Committees, Investigators’ Meetings, and other study-related meetings with external audiences. Build relationships with principal investigators and other relevant external stakeholders.
• Responsible for partnering closely with key stakeholders across Medical, including the Clinical Research Collaborations group, working on the cell therapy portfolio to ensure cohesiveness and one MEG voice.
• Fulfill GCP and compliance obligations for clinical conduct and maintains all required training.
• Employ strong business acumen and fiscal stewardship focused on driving reciprocal scientific value creation and allocate resources consistent with company priorities.