Director Safety Physician

About the role

The Medical Safety Physician (MSP) leads safety oversight for oncology clinical programs, ensuring patient protection throughout trial execution. Reporting to the Medical Safety Pharmacovigilance (MSPv) department, the Director collaborates with Safety Scientists and cross‑functional teams to shape safety strategy at the portfolio level.

Key responsibilities

• Accountable for quality performance of one or more safety management teams.
• Oversee safety monitoring, signal detection, and benefit‑risk assessment across product life cycles.
• Lead escalation, management, and communication of safety inquiries for assigned oncology products.
• Develop and present safety strategies to regulatory authorities and internal stakeholders.
• Ensure compliance with GCP, local regulations, and internal quality standards.
• Contribute to safety sections of regulatory documents such as DSURs, IBs, and clinical study reports.
• Participate in due‑diligence activities for licensing and acquisition initiatives.
• Mentor and train Safety Physicians and Safety Scientists.

Required profile

• Medical Degree (MD) or internationally recognized equivalent; MD/PhD or certified training in a relevant discipline is a plus.
• Extensive drug safety/pharmacovigilance experience in the biopharma/biotechnology industry, including innovative drug development, BLA/MAA submissions, and advisory committee participation.
• Strong background in oncology, preferably immuno‑oncology.

Required skills