10 ago
|
Alexion
|
Barcelona
Job Description
This is what you will do:
The Senior Medical Director, Clinical Development (Cell therapy) will lead the clinical sub-team and the global program team to build integral clinical development plans and contribute to developing asset-level and therapeutic area strategies. 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 the development of regulatory strategy, and being the clinical spokesperson at regulatory meetings, and provide medical oversight in the interaction with other disease areas.
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 Global 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 subteam and oversee the preparation of a clinical development strategy. May 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.
- Being actively involved in the selection and preparation of advisory board experts and help the team in preparation for meetings.
- Critically evaluate available information about diseases of interest, the competitive landscape and summerise information to support dissemination and incorporation into clinical development programs, asset plans and therapeutic area strategy.
- Lead the clinical sub-team and oversee multiple studies for a given program. Serve as the Medical input to the Global Medical Lead, and manage various
📌 Senior Medical Director, Clinical Development Cell Therapy (Barcelona)
🏢 Alexion
📍 Barcelona