Alexion Pharmaceuticals, Inc.
Medical Director, Clinical Development Nephrology
Alexion Pharmaceuticals, Inc. invites applications for the Medical Director, Clinical Development in Nephrology. This role leads or supports clinical sub‑teams and the global Program Team (GPT) in building and executing clinical development plans for therapeutic area and asset strategies.
Responsibilities
- Lead or support the clinical subteam, overseeing design and execution of multiple clinical programs.
- Represent Clinical Development on the GPT and at management and review committees.
- Supervise and develop medical monitors and/or clinical development scientists.
- Lead study teams in preparing protocols, charters, statistical summaries, presentations, publications, and clinical sections of regulatory documents.
- Develop medical content for regulatory submissions (NDAs/BLAs, sNDAs/SBLAs, briefing packages, etc.).
- Identify and coordinate external experts for advisory boards, steering committees, adjudication committees, and data monitoring committees.
- Critically evaluate disease information, competitive landscape, and synthesize findings for integration into program and strategic plans.
- Provide medical input to the Global Development Team/Subteam and serve as the Medical Expert for study teams.
- Conduct medical monitoring during vacations, restructures, or other staffing changes.
- Present clinical trial data to senior management.
- Collaborate internally across biostatistics, data management, pharmacology, safety, quality, and project management.
- Maintain data integrity across all clinical trials.
Qualifications
- ynthia