Associate Director Global Clinical Development Operations Biobanking

Role Summary

Associate Director of Biobanking responsible for compliant, efficient handling of clinical biospecimens at trial closeout and during long-term storage. Develop governance for sample retention and disposition, maintain GCP and patient consent compliance, and drive operational excellence in collaboration with cross-functional teams. Contribute to the configuration and implementation of a next-generation biospecimen management system to enable biobanking and end-of-trial storage capabilities, and support Biorepositories and the Biospecimen Management Center of Excellence.

Responsibilities

• Oversee biobanking and long-term storage (LTS) of clinical biospecimens from 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 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 assignments under the CoE remit.
• Implement tools and trackers for visibility and compliance of LTS activities; ensure timely documentation and audit readiness.
• Actively contribute 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
• Ability to take ownership, act quickly, and work under pressure
• Experience in (global) project management and working in a matrix organization
• Experience with common software (Word, Excel, PowerPoint, MS Project)
• Attention to detail, analytical thinking, and problem-solving skills
• Experience coordinating and guiding team members
• Ability to recognize problems and provide solutions
• Good organizational and communication skills