The Executive Medical Director serves as a senior member of the DSPV leadership team, accountable for the management, mentoring and development of assigned benefit-risk management staff as well as serving as a global safety officer for assigned investigational and/or marketed products.
Requirements
- Prior career success as a product safety physician
- Managing and developing individuals and highly effective teams
- Providing safety leadership and advisement in several company-wide forums and initiatives
- Strategic advisement on clinical development plans, design of clinical protocols
- Analysis strategy for Integrated Summary of Safety (ISS) and benefit-risk content within the Clinical Overview documents associated with regulatory filings
- Responsible for the content of Risk Management Plan/ REMS as required
- Acquire a deep understanding of the disease process and assigned product(s) efficacy and safety profile
- Ability to effectively communicate and respond to product safety queries from all sources including ethics committees and regulatory authorities
