Vice President, Global Clinical Medicine
China
America
Position Summary
We are currently seeking an exceptional leader as Vice President, Global Clinical Medicine to join our team. The VP, Clinical Medicine will lead the clinical development strategy, execution, and clinical trials. You will be the primary point person for medical oversight of clinical studies with responsibilities to include clinical trial design, protocol development, medical monitoring, review and interpretation of clinical trial data, drafting key clinical documents such as protocol, CSR, briefing package, IND, NDA, BLA, etc. This role will be responsible for timely execution of deliverables in close collaboration with relevant internal and external partners.
Essential Duties and Responsibilities:
- Lead the design and writing of clinical protocols and associated clinical documents contribute as an author with the writing of abstracts, posters and/or meeting presentations.
- Keep up to date with compliance, SOPs and adhere to ICH, GCP, and relevant regulatory guidelines.
- Collaborate closely with Clinical Operations and be accountable for clinical trial conduct and timelines for associated key deliverables.
Qualifications and Experience:
- Ph.D. in Medicine or related field.
- At least 7 years of clinical research experience, with 3+ years in management.
- Experience with NDA, BLA or MAA submission(s). Drug approval(s) a plus.
- Integrated understanding of FDA, NMPA, EMA, ICH, and GCP guidelines. Prior interactions with FDA, NMPA and EMA regulatory agencies is desirable.