Director, Biospecimen Management Cell Therapy & Early Oncology
Bristol Myers SquibbAbout the role
Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
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. Read more: careers.bms.com/working-with-us.
Position Summary
The Director of Biospecimen Management for Cell Therapy & Early Oncology will efficiently and independently perform the duties and responsibilities outlined below.
Duties/Responsibilities
- Lead the Biospecimen Management Team supporting CT and Early Oncology studies, including goal setting, deliverables, performance management reviews, and coaching.
- Oversee and provide guidance on the development of comprehensive program and protocol-level biospecimen management plans for all studies.
- Ensure the timely and efficient delivery of all biospecimen operational aspects of clinical studies across all stages (start-up, conduct, and close-out) with appropriate quality oversight and standards.
- Escalate issues to appropriate functional areas when there are deviations from established standards or recommended guidelines.
- Maintain knowledge of existing and new regulatory guidance related to biospecimen management.
- Enhance IT capabilities to improve operational effectiveness, biospecimen tracking, and performance metrics capture.
- Seek opportunities to enhance the value of external vendor relationships (e.g., Central Laboratory, 3rd party specialty labs) through early strategic engagement and ongoing partnership.
- Engage and partner with all GDO functions, other R&D functions, and key internal and external stakeholders to improve organizational knowledge and maturity on risk and issue management in the biospecimen space.
- Develop and update policies, standard operating procedures (SOPs), and working procedures (WPs) related to biospecimen planning and utilization.
- Maintain awareness of market trends and industry best practices and incorporate findings into day-to-day operations, including involvement in key external organizations (e.g., SCOPE, SLAS, ISBER) related to biospecimen management.
- Ensure compliance in biospecimen management areas, partnering with site-facing roles to address timeliness of query resolution and specimen compliance.
- Collaborate with data management to ensure oversight of database lock delivery.
- Support outsourcing management in efficient and effective governance meetings, serving as a key member and advisor to operational and strategic management committees and additional project meetings and escalations as necessary.
- Develop and retain a diverse workforce while ensuring adequate work-life balance.
- Assign and maintain the Book of Work for the organization, ensuring proper and timely functional support of trials.
- Develop and maintain organizational metrics.
- Serve as the integration/collaboration lead for other strategic and process improvement initiatives across internal and external organizations.
- Coordinate feedback on imaging management-related findings for all internal and external site audits, follow up on corrective and preventative actions to completion and implementation, and serve as a functional expert on internal audits and vendor visits.
- Handle personnel hiring, training, performance, compliance, and development for the Biospecimen Management team.
- Provide side-by-side coaching, deliver performance evaluations, and set goals for the team. Mentor and maintain motivation
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