BioNTech SE · 2 days ago
Director, Global Clinical Operations (US Remote)
United States
Full-time
Remote
Director/Executive
$168K/yr - $269K/yr
12+ years expBioNTech SE is a company dedicated to transforming patient lives through innovative therapies. As the Director of Global Clinical Operations, you will lead clinical development operations across therapeutic platforms, ensuring high-quality execution of clinical trials and fostering collaboration with internal and external partners.
Health Care
Responsibilities
Lead one or multiple therapeutic platforms within BioNTech's pipeline, ensuring consistent execution across compounds and vendors
Drive cross-functional collaboration with internal departments, external vendors, and global partners to align strategies and achieve operational goals
Develop portfolio documents such as oversight plans, process developments (including Trial RACI), and SOPs to streamline operations
Supervise adherence to regulatory requirements, ICH-GCP guidelines, and internal procedures while ensuring proper training for team members
Provide operational insights into feasibility studies, timeline planning, and cost estimations during clinical program development
Act as a key escalation point for platform-level challenges while delivering innovative solutions for operational hurdles
Manage resource forecasting and allocation for clinical studies across programs while overseeing CTM/CTS staff recruitment, mentoring, training, and compliance
Qualification
Required
Bachelor's degree in life sciences or related field; PMP certification desirable
Minimum 12 years of experience in pharmaceutical/biotech industry with 8+ years leading global clinical development teams
Proven ability to foster cross-functional collaboration with internal teams and external partners to achieve shared goals
Profound knowledge of ICH-GCP guidelines and legislation for clinical research projects; experience addressing regulatory inspections or audits
Strong communication skills with confident presentation abilities; fluent in English
Advanced project management skills including risk management, performance monitoring, teamwork, and problem-solving
Strategic thinker with a proactive approach to managing ambiguity in dynamic environments
Experienced in building high-performing teams through talent development, coaching, and fostering trust
Preferred
PMP certification desirable
Benefits
Competitive remuneration packages
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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