Senior Medical Director, Clinical Development (Cell therapy)
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This is what you will do:
The Senior Medical Director will lead the clinical sub-team and the global program team to build global clinical development plans and contribute to developing asset-level and therapeutic area strategies. The role is responsible for overseeing the clinical development strategy development and execution for late-stage programs, leading the clinical subteam to the GPT, representing clinical development on the GPT, contributing to regulatory strategy development, and acting as the clinical spokesperson at regulatory meetings.
You will be responsible for:
Lead or support the clinical sub-team and oversee the design and execution of multiple clinical studies or programs in benign auto/allo‑immune derived conditions.
Represent Clinical Development on the Integral Program Team (GPT) and in presentations at management and review committees (e.g., Clinical Document Review Committee, Development and Commercial Steering Committee).
Supervise and develop Medical Directors, CDS, and/or fellows; lead a clinical sub-team and oversee the preparation of a clinical development strategy.
Lead one or more clinical study teams in preparing clinical study‑related documents, including protocols, charters, statistical summary reports, meeting presentations, publications, and clinical sections of regulatory documents.
Select and prepare advisory board experts and help the team prepare for meetings.
Critically evaluate information about diseases of interest, the competitive landscape, and summarise findings to support dissemination and incorporation into clinical development programs, asset plans and therapeutic area strategy.
Serve as the Medical input to the Global Medical Lead, the Global Development Team/Subteam, and the Medical Expert for clinical study teams. xpzdshu
Liaise internally with other clinical development team members and external partners to drive overall program strategy and development.
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