RayzeBio Safety MD Senior Director

Role: Safety MD oversees global pharmacovigilance and safety science for RayzeBio's radiopharmaceutical oncology portfolio, providing leadership in proactive safety surveillance, signal detection, risk management, and benefit-risk assessments. Responsibilities include developing safety strategies, ensuring compliance with FDA, EMA, ICH guidelines, integrating safety insights into product development and regulatory activities, and representing safety in regulatory interactions and safety committees. Key duties also encompass daily SAE/ICSR case reviews, safety content preparation for regulatory filings, and mentoring safety team members. Requirements: MD or equivalent with 10+ years in pharmacovigilance, safety science, or related pharma/biotech field; strong knowledge of global PV regulations, signal detection, risk assessment, and experience engaging with regulatory authorities. Preferred qualifications include radiopharmaceutical or oncology safety expertise and NDA/MAA submission experience. Skills include leadership, communication, cross-functional collaboration, and a commitment to patient safety. High-Value: Oncology (radiopharmaceuticals), global safety leadership, proactive safety surveillance, signal detection, risk management, regulatory compliance, and experience with regulatory submissions. Work setup involves global responsibilities with 25% travel, based in Princeton, NJ.