The BioSpecimen Management (BSM) is a group in the Process and Support Function, which is part of Biomarker and Bioanalytical Development at Alexion Research in New Haven, CT. BSM maintains a clear vision of building a cost effective, scalable program focused on meeting the human biospecimen needs of Alexion's Research and Development activities strategically aligned to enhance diagnostic, preventative and therapeutic efforts. The team operates with the mission to deliver a diverse, well characterized high quality human biospecimen, cell cultures and panels. BSM maintains a data repository with appropriate human subject protection and industry best practices.
Alexion acquires a variety of biological materials, primarily of human origin, banked or prospectively collected from geographically diverse populations, and coordinate panel builds tailored to specifications defined by projects in close collaboration with functional area experts and qualified commercial and non-commercial sources and suppliers. Biospecimens are characterized to fit the purpose, processed, distributed, and/or stored in the biorepositories until final disposition. Material traceability is electronically maintained in a validated laboratory information management system.
The Biobank Senior Director will oversee day-to-day operating activities of the Biorepository including specimen acquisition, inventory management, database management and quality control efforts. The Biobank Senior Director will also lead business development efforts through interfacing with specimen and clinical research sponsors. This position is charged with developing and building the initial BioBank as well as continually exploring areas and ways to collaborate with external biobank services.
Preferred qualifications for this position include an advanced degree in a scientific discipline, experience in clinical compliance, experience leading in a cross-functional biotech or pharma drug development setting, superior cross-functional and cross-company, collaboration skills and highly effective influencing skills.
- Develop department strategy, goals, and vision in alignment with organizational priorities.
- Provide professional development and manage the performance evaluation process.
- Manage biospecimen management annual operating budget and long-range plan.
- Oversee and advise on key activities performed by R&D including annual sample forecasting/planning, clinical trial operations, vendor performance management, use/reuse policy development and execution.
- Provide operational leadership in the area of biospecimen management.
- Track functional performance against budget and resource targets.
- Act as Business Process Owner (BPO) for biospecimen related SOPs and associated infrastructure (e.g., biobank database).
- Advise and oversee biospecimen-related preferred vendors and partnerships.
- Act as an escalation point for any study or portfolio level risks/issues as they pertain to biospecimen collection, management and/or destruction.
- Represent Biospecimen Operations on cross-functional governance bodies and escalate sample related issues to the Sample Governance Committee, biomarker research and development, and translational sciences.
- Identify and establish partnerships with internal research scientists, Business Unit scientists, and external groups to align the appropriate technology, clinical samples, and strategy with the clinical questions for the project.
- Serve on multi-site committees focused on biomarker research application and technology development.
- Define and report on key metrics related to biospecimen management performance and capacity.
- Identifies gaps and leads process improvement efforts for best practice.
- Identify, negotiate and execute on partnerships with academic and medical institutions, and other initiatives to gain access to biobank samples and data with the aim to identify patients and enhance our understanding of diseases.
- Assisting in the development and execution of complementary strategies to gain access to patient samples and data, such as through pre-competitive consortia, third-party aggregators, and other mechanisms.
- Minimum of 10+ years of biopharmaceutical R&D experience in drug development and participation in projects involving cross-functional teams
- Proven track record of leading successful projects
- Adept at leading cross-functional development teams that include subject matter experts in clinical, project management, regulatory, quality, commercial, manufacturing, and discovery research.
- Knowledge of preclinical and clinical drug development is a prerequisite
- Knowledge of rare disease landscape
- Excellent written, verbal and visual communication skills as evidenced by a track record of publications, posters and/or presentations
- Advanced degree (MSc, PhD or MD) in the life sciences or regulatory compliance.
- Strong record of deal negotiation and execution, creative partnership structuring
- Experience in precision medicine, biomarkers, or diagnostics preferred in rare diseases (complement, metabolic, neurologic, or bone diseases).