BioNTech SE · 7 hours ago
Director, Global Clinical Operations
Cambridge, MA
Full-time
Onsite
Director/Executive
$168K/yr - $259K/yr
12+ years expBioNTech SE is a leader in the biotechnology sector, focusing on revolutionizing cancer care and infectious disease treatment. They are seeking a Director of Global Clinical Operations to lead clinical development operations, ensuring high-quality execution across compounds and vendors while collaborating with senior management and external stakeholders.
Health Care
Responsibilities
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
Qualification
Required
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
Benefits
Competitive remuneration packages
Variety of benefits in support of our diverse employee base
Company
BioNTech SE
At BioNTech we understand that every cancer patient’s tumor is unique and therefore each patient’s treatment should be individualized.
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
James Ryan
Chief Legal Officer and Chief Business Officer
Recent News
2025-10-21
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