Director Safety Physician

As a Medical Safety Physician in our MSPv team, you will guide safety across oncology programs, shaping risk management and signaling strategy. You collaborate with Safety Scientists to ensure patient safety during clinical development and contribute to key safety documents and regulatory submissions. You will influence safety strategies at the portfolio level, engage with regulatory authorities, and mentor safety professionals. This is a strategic safety leadership role within a fast-moving oncology portfolio, offering impact across trials, workflows, and cross-functional collaboration.

• annual bonus
• equity
• benefits vary by location

• Accountable for the quality performance of one or more safety management teams
• Oversees safety monitoring, signal management, and benefit-risk assessment across product life cycle
• Leads escalation and communication of safety inquiries for assigned products
• Shapes the optimal safety strategy for oncology programs at the portfolio level
• Interacts with Regulatory Authorities on safety matters
• Ensures high-quality safety contributions to documents (DSURs, IB, clinical study reports)
• Participates in due diligence for licensing/acquisition initiatives
• Represents MSPv in alliance management projects and safety data exchange agreements
• Acts as safety SME and arbiter for safety issues within programs
• Ensures compliance with laws, regulations and quality standards; mentors Safety Physicians/Scientists

• Medical Degree (or internationally recognized equivalent); MD/PhD or relevant medical discipline training is a plus
• Extensive drug safety/pharmacovigilance experience in biopharma/biotech with innovative drugs and regulatory submissions
• Experience with US regulatory strategies for oncology products
• Proven ability to operate in a matrix, multidisciplinary team and implement GCP in clinical trial safety reporting
• Demonstrated experience with safety in regulatory documents and safety reporting requirements

• Cross-functional collaboration
• Communication with regulatory bodies
• Leadership and mentorship
• Pharmacovigilance and safety signal detection
• Safety data assessment and risk management
• DSURs, Investigator Brochure, regulatory safety reporting