Director, Biospecimen Operations Management
- Princeton, NJ
At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science.In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
We are developing a world-class Global Biospecimen and Imaging Management (GBSIM) organization within Global Development Operations (GDO) to drive excellence and innovation in end-to-end biospecimen and imaging management to support the objectives of both Research and Development. Planning and operationalizing the clinical trial biospecimen plan is critical to support these objectives are key.
As such, we are recruiting a Director of Biospecimen Operations Management to head a team of Biospecimen Operations Managers; who work closely with vendors, scientists and clinicians to provide biospecimen operational logistics and management for BMS-sponsored Phase 1-2a clinical trials and externally acquired biospecimens; support and execute asset and protocol level biospecimen strategies; work across the organization and BMS's partners to inform, implement, and project manage operational efforts to execute these strategies. Critical to this role is the ability to provide innovative solutions to oversee timelines for specimen data delivery and thereby, enabling quick decision-making and ensuring BMS's continuous competitive advantage. The individual will be responsible for supporting biospecimen management for Early Development, Clinical Pharmacology and Cell Therapy studies with opportunities to contribute toward optimizing work streams cross functionally throughout the organization as it relates to biospecimens.
- Provide strategic oversight and line management to a team in biospecimen operations, supporting multiple protocols and therapeutic areas with core expertise in Good Clinical Practice (GCP), clinical trial operations, data, vendor, risk and project management.
- Responsible for ensuring the timely and efficient delivery of all biospecimen operational aspects of dynamic clinical studies, across all stages (start-up, conduct and close-out), in alignment with program testing strategy, with appropriate quality oversight and data standards.
- Experienced in the execution and maintenance of a GBSIM Book of Work to facilitate cohesive and uniform transparency across Biospecimen Operations Managers; also, responsible for his/her own complex, highly visible, Book of Work.
- Maintains knowledge of existing and new regulatory guidance as it pertains to clinical biospecimen management. Partners with site-facing roles to ensure compliance on biospecimen management areas like processing instructions and applicable regulations/guidance to promote integrity of research biospecimens. Advices on proper documentation and/or resolution on biospecimen management issues.
- Seeks opportunities to enhance value of external vendor relationships through early and frequent strategic engagement and ongoing partnership.
- Supporting vendor alliance leads in efficient and effective governance meetings, including being a key member and advisor to operational management committees and additional project meetings and escalations as necessary.
- As appropriate, assist in the development of global SOPs, Work Instructions and Job Aides to support biospecimen operations management activities.
- Evaluate technologies to identify opportunities to enhance operational biospecimen effectiveness and metadata tracking.
- Develop and drive strategies for collaborative continuous improvement initiatives to streamline and improve operational processes across a multitude of vendor types as well as procedures to standardize biospecimen nomenclature, collection, use, data transfer and storage.
- Instill a culture of excellence and innovation throughout the organization.
- Develop and retain a diverse workforce while ensuring adequate work-life balance.
- Additional responsibilities may be assigned as needed.
- Travel expectations are minimal, perhaps 5-10%.
- B.S., M.S. in a scientific discipline; direct line management experience; with experience in Biospecimen Operations or Clinical Study execution desired.
- Minimum 10+ years of academic, biotechnology or pharmaceutical industry experience. Coaching and mentoring experience a plus.
- Highly flexible, results oriented and who enjoys working in a fast-paced dynamic changing environment.
- Advanced knowledge of GCP/ICH, biospecimen management systems, clinical development processes and R&D/clinical laboratory techniques is desirable.
- Knowledge of clinical biospecimen procedures including: complex biospecimen sampling plans and lifecycles, collection and tracking procedures, logistics considerations, chain of custody, issue escalation/resolution and data management highly desired.
- Prior experience selecting, managing and developing relationships with biospecimen management vendors.
- Strong and effective management of cross-functional, multi-cultural, on-site and remote teams; demonstrated ability to work and influence within a matrix structure.
- Strong written and oral communication skills with experience in developing training and/or informational material and presenting to both internal and external stakeholders.
- Experience and advanced fluency with MS Office tools (esp. MS Excel, MS PowerPoint, MS Visio and MS Project).
- Ability to adopt a biopharma enterprise-wide and entrepreneurial mindset, to act with a sense of urgency, accountability and integrity, and to have fun along the way.
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.
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