Oversee one or more therapy platforms within BioNTech’s pipeline, ensuring consistent execution across compounds and vendors
Lead global study management and vendor oversight with direct report management responsibilities
Develop and review portfolio documents such as Oversight Plans, SOPs, Trial RACI frameworks, and process improvements
Ensure regulatory compliance (ICH-GCP guidelines) through training supervision and adherence monitoring
Provide operational insights into feasibility studies, timeline planning, and cost estimation during clinical program development
Forecast resources for clinical studies while managing CTM/CTS staff recruitment, performance evaluation, training, coaching, and professional development

Bachelor’s degree in life sciences or related field; advanced degree preferred
Minimum 12 years of experience in pharmaceutical/biotech industry with 8+ years leading cross-functional teams in Global Clinical Development
Strong knowledge of international guidelines (ICH-GCP) for clinical research projects; experience with regulatory inspections or internal process audits is essential
Proficient in Microsoft Office programs (Word, Excel, PowerPoint) with knowledge of electronic data systems like eTMF or EDC
Strategic thinker capable of identifying opportunities and managing risks while fostering collaboration across functions
Proven ability to build high-performing teams through talent development and coaching while maintaining integrity under pressure.

Director, Global Clinical Operations

Key skills