Medical Safety Physician (MSP)

Job title: Medical Safety Physician (MSP)

About the Role The Medical Safety Physician (MSP) supports oncology programs by providing medical safety expertise to study management teams and ensuring patient safety across the clinical trial process, in collaboration with Safety Scientists. The MSP contributes to trial protocols, investigator training, safety data assessment, safety signal detection, and regulatory reporting, and helps prepare safety documents such as DSURs, Investigator Brochures, and Clinical Trial Reports. This role offers a strategic opportunity within BioNTech’s Medical Safety Pharmacovigilance (MSPv) department.

What You'll Do

• Accountable for the quality performance of one or more Safety Management Teams (SMTs).
• Oversee safety monitoring, signal management, and benefit-risk assessment for assigned products across the life cycle.
• Identify and lead escalation and communication of safety inquiries and concerns.
• Formulate and drive optimal safety strategy for assigned oncology programs at the portfolio level.
• Interact with Regulatory Authorities on safety matters.
• Ensure high-quality safety contributions to documents (briefing books, Investigator Brochures, safety sections of clinical study reports, regulatory responses).
• Participate in due diligence for Licensing/Acquisition and represent MSPv in alliance management projects.
• Serve as safety subject matter expert and arbiter for portfolio safety issues.
• Ensure compliance with law, global/local regulations and quality standards.
• Train and mentor Safety Physicians and Safety Scientists.

What We're Looking For

• Medical Degree (or internationally recognized equivalent); MD/PhD or certified training in a medical discipline a plus.
• Extensive drug safety/pharmacovigilance experience in biopharma/biotech, including development of innovative drugs, BLA/MAA submissions, and advisory committee experience; immuno-oncology/inflammation focus preferred.
• Experience with Regulatory Agencies on development strategies for oncology products, especially in the US.
• Proven ability to operate in a matrix organization and with multidisciplinary teams; experience implementing GCP in safety reporting.

Compensation & Benefits

• Salary range: $168,100 – $268,700 per year (USD), plus benefits, annual bonus and equity; actual compensation varies by responsibilities, education, experience, and location.
• Benefits vary by location; BioNTech offers a comprehensive package and opportunities for growth.