Senior Director, Medical Governance & Operations Lead | Pharmacist (m/w/d)
BioNTech SE
Job Summary
This Senior Director role is pivotal in establishing and enhancing the global framework for compliant, efficient, and patient-focused Medical Affairs activities. The successful candidate will integrate governance, risk management, and operational excellence to safeguard the organization while ensuring timely delivery of scientific initiatives. Day-to-day responsibilities include reviewing and updating global Medical Affairs policies, conducting risk assessments, leading audit readiness efforts, and optimizing operational processes. The role also involves overseeing Phase IV research, managing medical review processes, and leading collaborative research studies. Strong leadership, a deep understanding of evolving regulations, and a commitment to integrity are essential for this high-impact position.
Required Skills
Education
Not specified
Experience
- Professional experience in establishing, maintaining, and improving global frameworks for Medical Affairs activities
- Experience in integrating governance, risk management, and operational excellence
- Experience in reviewing, harmonizing, and updating global Medical Affairs policies and SOPs
- Experience in conducting regular risk assessments and implementing mitigation plans
- Experience in leading global pre-audit self-inspections and managing CAPAs
- Experience in driving strategic initiatives for operational streamlining
- Experience in overseeing end-to-end planning and execution of Phase IV and observational studies
- Experience as global business owner for MLR review processes
- Experience in owning governance and operational frameworks for CRS/IITs
- Experience in establishing and managing compassionate use/expanded access programs
- Experience in developing and delivering training modules on governance processes
- Experience in leading, mentoring, and developing high-performing teams
Languages
Additional
- Not specified
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