Director, Safety Physician

Role: Lead pharmacovigilance medical activities for Summit's oncology investigational and marketed products, ensuring safety oversight across clinical trials and post-marketing. Responsibilities: review and assess ICSRs, prepare safety analyses and reports, support regulatory compliance, contribute to safety signal detection, review protocols for safety content, liaise with vendors and internal teams, mentor safety physicians, and maintain inspection readiness. Requirements: MD/DO or international equivalent with 10+ years as a safety physician; strong knowledge of oncology therapies, immunotherapy, chemotherapy; proficiency in safety databases, MedDRA coding, and global pharmacovigilance regulations; experience in safety data analysis and safety document authoring. HighValue: Oncology focus, immunotherapy, chemotherapy, Phase 3 clinical studies, safety signal detection, global pharmacovigilance, regulatory reporting, team leadership, cross-functional collaboration. WorkSetup: not specified; likely office-based or hybrid given seniority and scope.