Senior Medical Director, Product Safety Physician Lead

Role: Senior Medical Director and Lead Product Safety Physician for complex, multi-indication oncology development programs, primarily in early clinical stages. Responsibilities: oversee benefit/risk safety profiles, lead safety governance including Safety Management Teams and external safety committees, manage safety issues and escalation processes, contribute to labeling and safety communications, support clinical trial safety content and safety monitoring, and lead pharmacovigilance activities including risk management and safety surveillance. Collaborate with product development, Medical Affairs, regulatory, and external stakeholders; mentor junior safety staff. Qualifications: MD with at least 6 years in clinical research/biopharma, including 4+ years in safety and experience in Phase 1/2 oncology; fellowship and clinical experience preferred. Expertise in global pharmacovigilance regulations, safety data analysis, and safety database tools (MedDRA, Spotfire). High-Value: oncology, early development (pre-IND, Phase 1/2), pharmacovigilance, safety oversight, regulatory interactions, and cross-functional safety governance. Travel: less than 10%. Work Setup: not specified, likely hybrid or on-site.