Director Safety Physician

Responsibilities

• Provide medical safety expertise to oncology study management teams to ensure patient safety throughout clinical trials.
• Oversee safety monitoring, signal management, and benefit-risk assessments for assigned products throughout their life cycle.
• Formulate and drive optimal safety strategies for oncology programs at the portfolio level.
• Lead the escalation, management, and communication of safety inquiries and concerns.
• Oversee the quality of safety content in regulatory documents, including Investigator Brochures, Clinical Study Reports, and briefing books.
• Interact with Regulatory Authorities on safety matters and participate in due diligence for licensing and acquisition initiatives.
• Represent the Medical Safety Pharmacovigilance department in alliance management and joint oversight committees.
• Train and mentor Safety Physicians and Safety Scientists.

Requirements

• Medical Degree (MD) or internationally recognized equivalent.
• Extensive drug safety and pharmacovigilance experience within the biopharmaceutical or biotechnology industry.
• Proven experience with BLA/MAA submissions and working with Regulatory Agencies (particularly in the US).
• Strong knowledge of Good Clinical Practice (GCP) standards and global/local safety reporting regulations.
• Demonstrated ability to achieve results within a matrix organization and multidisciplinary team.

Preferred Qualifications

• MD/PhD or certified training in a relevant medical discipline.
• Specific experience in immuno-oncology or inflammation therapeutic areas.
• Experience with advisory committee processes.

Benefits

• Competitive remuneration packages based on role, location, and experience.
• A dynamic and diverse workplace focused on medical innovation.
• Opportunities for meaningful career growth within a mission-driven organization.

About the Company

BioNTech is a biotechnology company dedicated to revolutionizing medicine by translating cutting-edge science into survival. We focus on addressing high medical needs, such as cancer and infectious diseases, through innovative therapies.