Associate Director Global Clinical Development Operations Biobanking
Scorpion Therapeutics, Cambridge, Massachusetts, us, 02140
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
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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
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