Senior Manager, Biospecimen Lead

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.