Associate Director Global Clinical Development Operations Biobanking

BioNTech•Gaithersburg, MD

About The Position

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.

Requirements

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 u sed 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

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.

Benefits

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