RayzeBio Safety MD Senior Director
Core
Lead global pharmacovigilance strategy, safety surveillance, signal detection, risk management, and benefit-risk assessment for radiopharmaceutical oncology therapies.
Role type
Senior Director, Safety Medical Director (MD)
Builds
Radiopharmaceutical oncology therapies
Domain
Oncology / Radiopharmaceuticals / Pharmacovigilance
Required skills
Pharmacovigilance strategy, signal detection, risk management, benefit-risk assessment, aggregate safety reporting, regulatory authority interaction, SOP development, cross-functional leadership, AI adoption for safety programs
Preferred skills
Radiopharmaceutical experience, Oncology safety experience, NDA/MAA/JNDA submission experience
Technologies
AI tools for safety program prioritization and adoption
Responsibilities
Lead global pharmacovigilance strategy and proactive safety surveillance; Establish safety governance structures and SOPs; Partner with clinical, regulatory, and medical affairs teams to integrate safety insights; Direct safety evaluation and benefit-risk assessment for clinical and post-marketing products; Represent Safety Science in Safety Management Teams and regulatory submissions; Perform daily ICSR/SAE case reviews; Mentor cross-functional colleagues and safety team members; Serve as backup Safety MD for the PV Head.
Seniority
Senior Director, hands-on IC with leadership responsibilities