Director Safety Physician

Responsibilities

• Provide medical safety expertise to oncology study management teams to ensure patient safety and regulatory compliance.
• 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 or pharmacovigilance experience within the biopharmaceutical or biotechnology industry.
• Proven experience with BLA/MAA submissions and working with Regulatory Agencies (particularly US agencies).
• Experience implementing GCP standards in clinical trials and managing safety reporting.
• 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 including annual bonus and equity.
• Comprehensive benefits package designed to support employee wellbeing.
• Opportunity to work in a dynamic, diverse, and innovative biotechnology environment.

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 a community of innovators and scientists driven by a passion for advancing medicine and changing lives worldwide.