Medical Director, Patient Safety Physician

About the role

We are seeking a Medical Director, Patient Safety Physician to define and execute the clinical safety strategy for late‑stage and marketed medicines. You will lead risk identification, mitigation, and benefit‑risk assessments, ensuring patient safety while supporting rapid development of innovative cancer therapies.

Key responsibilities

• Define, implement and communicate clinical safety strategy for assigned medicines, including risk identification and mitigation.
• Review and endorse Patient Risk Management Plans, safety specifications, and pharmacovigilance plans.
• Represent Patient Safety on clinical and project teams, providing strategic medical mentorship.
• Oversee surveillance activities such as medical case review, signal detection, and SIRC activities.
• Provide medical input for labeling updates, regulatory submissions (NDA, BLA, MAA) and safety documentation (PBRER, PSUR, DSUR).
• Maintain a compliant, inspection‑ready pharmacovigilance system and support audit readiness.

Required profile

• Physician (MD or equivalent) with extensive experience in clinical safety and pharmacovigilance.
• Proven leadership in developing and executing safety strategies for late‑stage drug programs.
• Strong understanding of regulatory requirements for safety reporting and submissions.

Required skills

• Signal detection and medical case review.
• Pharmacovigilance reporting (PBRER, PSUR, DSUR).
• Regulatory submission preparation (NDA, BLA, MAA).
• Risk management plan development.

What we offer

• Opportunity to shape safety strategy for breakthrough oncology therapies.
• Collaborative, data‑driven environment with rapid decision‑making.
• Access to global resources and leading experts in drug development.