Director Safety Physician

Role: Medical Safety Physician supporting oncology clinical trials, responsible for assessing and managing patient safety throughout development. Responsibilities include safety data review, signal detection, safety strategy formulation, safety document preparation (DSURs, IBs, safety sections of reports), and ensuring GCP and regulatory compliance. The MSP also leads safety team performance, oversees safety monitoring, escalates safety concerns, and interacts with regulatory authorities. Additionally, the role involves contributing to due diligence, alliance management, and mentoring safety team members. Qualifications: MD or equivalent, extensive drug safety/pharmacovigilance experience in biopharma, preferably with immuno-oncology or inflammation focus; familiarity with BLA/MAA submissions and regulatory agency interactions; proven experience in matrix organizations and GCP standards. Preferred: MD/PhD or relevant medical certification. High-Value: oncology therapeutic area, immuno-oncology, clinical development, safety signal management, regulatory interactions. Work setup: US-based, full-time, with location flexibility; travel details not specified.