Sr Med Director Patient Safety

Senior Director, Patient Safety & Pharmacovigilance Location:

San Francisco or San Diego, CA Overview A clinical?stage biotech company with their first NDA slated for later this year is seeking a senior medical leader to oversee patient safety and pharmacovigilance across its oncology programs. The organization operates in a highly collaborative, science?driven environment and is looking for a tteam member who is self-motivated and ready to support the company during a critical moment in their development timeline. Role Summary Reporting to the VP Pharmacovigilance, the Senior Medical Director will lead medical safety strategy, signal evaluation, and benefit?risk assessment for the company's development portfolio. This position partners closely with cross?functional teams, contributes to regulatory submissions, and provides oversight for safety physicians and scientists. The role is onsite four days per week. Key Responsibilities Lead medical safety strategy, signal detection, and risk?management activities. Serve as a senior member of the safety leadership team. Oversee safety physicians/scientists and ensure high?quality safety operations. Review and contribute to global safety reports and regulatory submissions. Provide medical input on protocols, safety documents, and benefit?risk analyses. Support regulatory interactions and participate in monitoring committees. Contribute to due diligence and business development safety assessments. Review serious adverse events and support narrative development. Requirements M.D. or D.O. with completed residency. 8+ years of pharmacovigilance or drug safety experience. Strong knowledge of global safety regulations. Proven leadership and cross?functional collaboration experience. Excellent communication, analytical, and organizational skills. Authorization to work in the U.S.