Role at a glance
- Salary
- Not yet verified Check the description for pay details; an amount or pay period has not been verified.
- Location
- Princeton, New Jersey, United States
- Employment
- Full-time
- Experience
- Senior Level 5+ years academic, biotech, healthcare or pharmaceutical industry experience.
- Education
- Scientific degree (Associates, Bachelors, Masters, or higher), Project management or equivalent experience.
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Role Summary
The Senior Manager, Biospecimen Lead is an independent contributor who oversees biospecimen management, including collection, shipment, storage, analysis, and final disposition, within a therapeutic area or asset. The role serves as a member of the Core Clinical Team and biospecimen subject matter expert, influencing biospecimen strategies through risk mitigation, vendor oversight, and sample reconciliation.
What You'll Do
- Independently oversee biospecimen management in 5-15 clinical trials.
- Develop a Specimen Management Plan that highlights risks and provides mitigation steps.
- Track and reconcile biospecimen status using internal and external systems and create custom tracking solutions.
- Provide regular biospecimen status updates to the core clinical team on inventory, location, quality issues, and timelines.
- Act as liaison between clinical teams and vendors to coordinate biospecimen activities and independently resolve issues.
- Participate in vendor audits and resolve CAPA issues.
Generated from the employer's posting. Verify important details before applying.
View full postingQualifications
A scientific degree or project management or equivalent experience, with 5+ years of academic, biotech, healthcare, or pharmaceutical experience and advanced vendor and clinical research knowledge.
Required
- Scientific degree (Associates, Bachelors, Masters, or higher), or project management or equivalent experience
- 5+ years academic, biotech, healthcare or pharmaceutical industry experience
- Advanced vendor experience (e.g., Central Labs, Bioanalytical, Biomarker, CROs, Biospecimen Storage Vendors, etc.)
- Advanced understanding of clinical and biomedical research including GCP, GLP, CLIA, data management, risk management, and regulatory issues
- Strong communication skills; able to create and deliver presentations and data to knowledgeable audiences without supervision
- Able to support 5-15 clinical trials, PI-IV, ranging from mid to high complexity
- Makes decisions that require choosing between multiple options to resolve complex problems or issues
- Travel of 0%-5% of time, when required per study team request to support site training or vendor due diligence activities
Preferred
- Deep knowledge of clinical biospecimen procedures and lifecycle, including collection and tracking procedures, logistics, chain of...
Original job description
Content provided by the employer
Original job description
Content provided by the employer
At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.
Position Summary
The Senior Manager, Biospecimen Lead, is an independent contributor who oversees the biospecimen management (collection, shipment, storage, analysis, and final disposition) within a therapeutic area or asset. As a member of the Core Clinical Team and biospecimen subject matter expert, this role influences the development and implementation of biospecimen strategies through risk mitigation, vendor oversight, and sample reconciliation to ensure timely delivery of data. This role drives innovation through process improvements and technology adoption, fosters inclusion by aligning cross-functional stakeholders, and ensures urgency in biospecimen delivery for clinical decision-making.
Duties/Responsibilities
- Independently oversee biospecimen management in 5-15 clinical trials.
- Develop Specimen Management Plan, highlighting risks and providing mitigations steps.
- Provide biospecimen expertise in protocol authoring to ensure operational feasibility and regulatory compliance.
- Track and reconcile biospecimen status using internal and external systems; create custom tracking solutions.
- Enter biospecimen requirements into a contracting system and ensure vendor documents (e.g. lab manuals, lab specs) are aligned with protocol and sample management plan.
- Provide regular biospecimen status updates to core clinical team (inventory, location, quality issues, timelines).
- Adhere to/develop standard operating procedures and guidance documents
- Act as a liaison between clinical teams and vendors to coordinate biospecimen activities and independently resolve issues.
- Participate in vendor audits and resolve CAPA issues.
- Maintain study documents in ‘inspection ready’ state.
- Lead cross-functional projects aimed at optimizing workflows and integrating innovative technologies.
- Provide training and mentorship for new colleagues as well as junior team members
- Maintain advanced working knowledge of compound and study related biospecimen requirements. Seeks knowledge beyond own area of specialty
Qualifications
Education/Experience/ Licenses/Certifications:
- Scientific degree (Associates, Bachelors, Masters, or higher), Project management or equivalent experience.
Specific Knowledge, Skills, Abilities:
- Deep knowledge of clinical biospecimen procedures and lifecycle including: collection and tracking procedures, logistics considerations, chain of custody, issue escalation/resolution and data management highly desired.
- Advanced vendor experience (e.g., Central Labs, Bioanalytical, Biomarker, CROs, Biospecimen Storage Vendors, etc.).
- Makes decisions that require choosing between multiple options to resolve complex problems/issues.
- Able to support 5-15 clinical trials, PI-IV, ranging from mid to high complexity and prioritize tasks to meet company objectives.
- Serves as SME/coach for junior staff to autonomously support trials.
- Strong communication skills. Able to create and deliver presentation/information/data to knowledgeable audiences, without supervision.
- Demonstrates "Change Agility" by accepting new tasks and effectively working in multiple different operating models.
- Demonstrates inclusion by a) ready and willing source of information for CBI colleagues b) acting as mentor to colleagues b) active listening and gathering various points of views.
- Innovates to bring solutions that impact the TDS level or higher.
- 5+ years academic, biotech, healthcare or pharmaceutical industry experience.
- Advanced understanding of clinical and biomedical research including aspects such as: GCP, GLP, CLIA, data management, risk management, and regulatory issues.
Travel: Travel required is minimal, 0%- 5% of time, when required per study team request to support site training or vendor due diligence activities
We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.
Compensation Overview:
The starting pay range(s) listed above is for full-time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully – carefully considering the nature of the role, required skills, work location, schedule and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws. Compensation programs are reviewed on an ongoing basis and may be adjusted over time to reflect evolving market factors, and individual, team or Company performance.
Benefits:
Subject to the terms and conditions of the applicable plans then in effect, you may be eligible to participate in our comprehensive benefit plans – including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability).
U.S.-based exempt employees are eligible for Flexible Time Off (FTO), which provides paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year.
Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval), 11 paid company holidays, and 3 optional holidays.
Depending on eligibility, employees may also have access to additional time-off benefits, including paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs. Eligible employees also enjoy an annual Global Shutdown between Christmas Day and New Year's Day.
U.S.-based job seekers can explore full benefit offerings at https://careers.bms.com/benefits
How We Work
Where you work matters – because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.
Supporting People with Disabilities
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [email protected]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
Candidate Rights
BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
For roles based in Los Angeles County only: If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/
Data Protection
We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
If this posting is missing required information required by local law or incorrect, contact BMS at [email protected]with the Job Title and Requisition number. Do not send application-related inquiries to this email. To check your application status, please login to your Candidate Home Account.
R1607721 : Senior Manager, Biospecimen Lead
About the company
Bristol Myers Squibb
Large Enterprise
Bristol Myers Squibb is a global biopharmaceutical company committed to discovering, developing, and delivering innovative medicines that help patients prevail over serious diseases. With a focus on oncology, immunology, and cardiovascular health, the company leverages advanced science and technology to create transformative therapies that address critical unmet medical needs. Operating in more than 70 countries, Bristol Myers Squibb emphasizes collaborative efforts and strong partnerships in research and development to drive advancements in healthcare and improve patient outcomes worldwide.