Director, Global Clinical Operations
New Jersey, US; Cambridge, US; Gaithersburg, US; London, United Kingdom; Mainz, Germany | full time | Job ID: 10662
As Director, Global Clinical Operations, you will lead and strategically manage clinical development operations for at least one platform within BioNTech’s pipeline. Your role is pivotal in driving high-quality execution across compounds and vendors while contributing to our mission of revolutionizing cancer care and infectious disease treatment. You will be part of the Operations Extended Leadership Team led by the VP of Operations, collaborating with senior management, external vendors, and clinical study personnel to ensure seamless clinical trial delivery.
In this role, you will oversee global study management and vendor oversight while shaping portfolio strategies and ensuring adherence to regulatory standards. Your leadership will influence department goals, team dynamics, and operational excellence, enabling BioNTech to achieve its ambitious objectives.
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
Qualifications:
- 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
Expected Pay Range Director (US): $168,100/year to $258,700/year + benefits, annual bonus & equity (bonus and equity is variable and dependent on company and individual performance). *Compensation for the role will depend on several factors, including responsibilities of the job, education, experience, knowledge, skills, and abilities.
Your Benefits:
BioNTech is committed to the wellbeing of our team members and offers a variety of benefits in support of our diverse employee base. We offer competitive remuneration packages which is determined by the specific role, location of employment and also the selected candidate’s qualifications and experience.
Note: The availability, eligibility and design of the listed benefits may vary depending on the location. The final requirements for the individual use of our benefits are based on the company's internal policies and applicable law.
How to apply:
Apply now by sending us your application documents including Curriculum Vitae, copy of ID, copies of degree certificates and professional certificates, motivation letter as well as your contact details via our online form.
Please note:
Only applications sent via our online form shall be considered. By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider ‘HireRight’. You will be informed accordingly by your BioNTech-Recruiter.
We are looking forward receiving your application.