Senior Director, Medical Governance and Operations Lead | Life Scientist (m/w/d)
BioNTech SE
Job Summary
This senior leadership role is responsible for establishing, maintaining, and continuously improving the global framework for compliant, efficient, and patient-focused Medical Affairs activities. The incumbent will integrate governance, risk management, and operational excellence to safeguard the organization while enabling timely scientific and medical initiative delivery. Day-to-day tasks involve updating global policies (SOPs, work instructions) in line with evolving regulations (FDA, EMA, ICH, EFPIA, PhRMA), leading audit readiness, and driving operational excellence initiatives like workflow redesign and digital tool integration. A key focus is overseeing Phase IV/Post-Authorization research and managing the Medical-Legal-Regulatory (MLR) review process globally. This position requires strong leadership skills, deep expertise in medical compliance, and the ability to partner closely with Executive Directors, Clinical Development, Regulatory, and Compliance teams across global locations (Mainz, London).
Required Skills
Education
Not specified
Experience
- Professional experience establishing and maintaining global governance frameworks
- Experience serving as a Medical Affairs liaison with Compliance and Quality teams
- Experience leading pre-audit self-inspections and managing corrective actions (CAPAs)
- Experience overseeing the planning and execution of Phase IV and observational studies
- Professional experience managing Collaborative Research Studies (CRS) and Investigator-Initiated Trials (IITs)
- Leadership experience leading and mentoring a high-performing team
Languages
Additional
- The role requires reporting to the Executive Director, Medical Excellence. The position is based in Mainz, Germany and London, United Kingdom.
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