Associate Director Global Clinical Development Operations Biobanking

Cambridge, US; Gaithersburg, US; New Jersey, US   |   full time   |   Job ID: 9857 

As an Associate Director of Biobanking, you will take ownership of processes that ensure compliant, efficient, and high-quality handling of clinical biospecimens at trial closeout and during long-term storage. This includes developing governance frameworks for sample retention and disposition, maintaining GCP and patient consent compliance, and driving operational excellence in collaboration with cross-functional teams. You will also have the opportunity to help shape the configuration and implementation of a next-generation biospecimen management system to enable biobanking and end-of-trial storage capabilities—laying the foundation for digitalized, scalable workflows. While your primary focus will be biobanking and trial closeout, the role may also support broader activities under the Biospecimen Management Center of Excellence remit, such as in-trial biospecimen management and process improvement initiatives. Additional scope includes partnerships with long-term storage vendors and biorepositories. If you are passionate about optimizing trial closeout workflows and influencing how technology transforms biospecimen management, this role offers a chance to make a meaningful impact.

Responsibilities:

• Oversee biobanking and long-term storage (LTS) of clinical biospecimens from all BioNTech clinical trials after trial closeout, ensuring compliance with GCP and patient consent.
• Chair BioNTech’s Long-Term Storage Committee; develop and optimize decision-making processes for sample retention, destruction, and reuse requests.
• Partner with stakeholder functions (Clinical Operations, Translational Sciences, BASE, Data Management) to align on biobanking and LTS strategies.
• Develop and operationalize processes for study-end sample relocation to LTS vendors, including vendor management, budgeting, and compliance tracking.
• Manage collaboration with external CROs and LTS vendors and internal BioNTech laboratories storing clinical biospecimens.
• Be an active member of the Biospecimen Management Center of Excellence (CoE), supporting team goals and taking on assignments under the CoE remit.
• Implement tools and trackers for visibility and compliance of LTS activities; ensure timely documentation and audit readiness.
• Actively contributes to process improvement initiatives to streamline trial closeout workflows and enhance operational efficiency.
• Serve as deputy for BioNTech Sample Tracking and Reporting Tool process owner: support system implementation, trial onboarding, vendor integration, and system enhancements.
• Provide operational support to CoE initiatives, including digitalization of biospecimen workflows, standardization of processes, and training of team members.
• Contribute or lead GCDO and/or BioNTech initiatives and projects that support and develop the BOS organization.

Qualifications:

Education:

• Bachelor's degree in life sciences

Experience:

• Minimum of 5 years’ experience in biobanking/long term storage of clinical biospecimens

• Proven knowledge of clinical trial patient consent and GCP compliance

• Very good English (written and spoken), as well as refined colloquial and correspondence skills (written and spoken)

• Ready to take over responsibility and ability to rapidly enter in action and to work under stress conditions

• Experience in (global) project management, and used to working in a matrix team

• Experience in usual software (Word, Excel, Power Point, MS Project)

• Attention to details, analytical thinker & problem solver

• Experience in coordinating and guiding team members

• Able to recognize problems and provide solutions

• Good organizational and communicative skills

Expected Pay Range Director: $146,300/year to $234,100/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 US is committed to employee wellbeing and offers best-in-class benefits & HR programs to support an inclusive & diverse workforce. Salaried/Position-Targeted Hourly Employees working 30+ hours per week are eligible for our comprehensive benefits package. Benefits include but are not limited to:

• Medical, Dental and Vision Insurance
• Life, AD&D, Critical Illness Insurance
• Pre-tax HSA & FSA, DCRA Spending Accounts
• Employee Assistance & Concierge Program (EAP) available 24/7
• Parental and Childbirth Leave & Family Planning Assistance
• Sitterstream: Virtual Tutoring & Childcare Membership
• Paid Time Off: Vacation, Sick, Bereavement, Holidays (including Floating) & Year-End U.S. Shutdown.
• 401(K) Plan with Company Match
• Tuition Reimbursement & Student Loan Assistance Programs
• Wellbeing Incentive Platforms & Incentives
• Professional Development Programs
• Commuting Allowance and subsidized parking
• Discounted Home, Auto & Pet Insurance

…and more! More details to be shared.
 

Home to dozens of research institutions, biopharmaceutical companies, life science incubators, venture capital firms, and over 30 million square feet of laboratory space, Cambridge, Massachusetts has earned a reputation as the #1 life science cluster in the world. As part of the Greater Boston area, the city is often referred to as the "biotech supercluster" due to its high concentration of life sciences firms. This unique ecosystem is the result of a model partnership between academia and industry, fostering collaboration and innovation and driving the development of new therapies, medical devices, and diagnostics. As Cambridge’s thriving life sciences industry continues to evolve, the city remains a beacon of knowledge, innovation, and collaboration, poised to shape the future of science and technology.

Apply now - We look forward to your application!

Apply for our Cambridge, US; Gaithersburg, US; New Jersey, US location and simply send us your documents using our online form.

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.