BioNTech SE · 4 days ago
Associate Director Global Clinical Development Operations Biobanking
Cambridge, MA
Full-time
Onsite
Lead/Staff, Director/Executive
$146K/yr - $234K/yr
5+ years expBioNTech SE is a leading biopharmaceutical company focused on developing and commercializing innovative therapies. The Associate Director of Biobanking will oversee the compliant handling of clinical biospecimens and drive operational excellence while collaborating with cross-functional teams.
Health Care
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
Qualification
Required
Bachelor's degree in life sciences
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
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
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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