Director Clinical Operations | Life Scientist (m/w/d)
BioNTech SE
Job Summary
This Director Clinical Operations role involves leading clinical trial teams across global oncology programs, focusing on strategic execution and regulatory compliance. The successful candidate will be responsible for ensuring adherence to ICH-GCP guidelines, contributing to the development of essential portfolio documents like SOPs and Oversight Plans, and serving as the primary point of escalation for project challenges. A significant part of the role includes resource planning, line management, and supervision of Clinical Trial Managers and Associate Directors, actively fostering team development and identifying high-performance members. Key requirements include a minimum of 12 years of experience in global study organizations and project management, coupled with a background in life sciences or medicine. The Director will also oversee the strategic sourcing and governance of external vendors and CROs, ensuring successful project timelines and deliverables while supporting internal and external audits.
Required Skills
Education
University degree in Natural/Life Sciences or Medical background (e.g., Nurse, Medical Technical Assistant, or Pharmaceutical Technical Assistant experience is acceptable)
Experience
- Minimum 12+ years in project management, regulatory submissions, and global study organizations
- Profound knowledge and experience in relevant legislation and international guidelines (ICH-GCP) for the performance of clinical research projects
- Experience in line management and supervision of Clinical Trial Managers and Associate Directors Clinical Trial Management
- Experience in the governance structure and oversight of CROs and vendors
Languages
Additional
- Able to motivate and lead a team; Independent and proactive way of working; Able to recognize problems and provide solutions; Ready to take over responsibility; Work location in Mainz, Germany and/or London, United Kingdom
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