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.

Summary

Manager, Biospecimen Lead is an independent contributor who will work closely with our Clinical Teams to develop and implement biospecimen management plan for BMS-sponsored Phase 1-4 clinical trials. As a member of the Core Clinical Team, this role is responsible for engaging cross-functionally to develop and operationalize the specimen management plan and provide regular updates on status of samples. Critical to this role is the ability to provide solutions to oversee timelines for specimen data delivery and thereby, enabling quick decision-making and ensuring BMS’s continuous competitive advantage.

Responsible for supporting biospecimen management for studies with opportunities to contribute toward optimizing work streams cross functionally throughout the organization as it relates to biospecimens.

Duties and Responsibilities

✓Oversee biospecimen management in 5-12 clinical trials, with minimal supervision
✓Develop Specimen Management Plan, highlighting risks and providing mitigations steps.
✓Provide biospecimen input in protocol authoring to ensure operational feasibility and regulatory compliance.
✓Track and reconcile biospecimen status using internal and external systems.
✓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 standard operating procedures and guidance documents
✓Act as a liaison between clinical teams and vendors to coordinate biospecimen activities and resolve issues with minimal supervision.
✓Participate in vendor audits and assist with CAPA resolutions.
✓Maintain study documents in ‘inspection ready’ state.
✓Participate in cross-functional projects aimed at optimizing workflows and integrating innovative technologies.
✓Provide training and mentorship for new colleagues
✓Maintain intermediate knowledge of therapeutic area and study related biospecimen requirements.

Qualifications

Specific Knowledge, Skills, Abilities

✓Intermediate 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.
✓Intermediate 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 5-12 clinical trials, PI-IV, ranging from low to high complexity and prioritize tasks to meet company objectives.
✓Able and willing to train new colleagues
✓Effective communication skills. Able to create and deliver presentation/information/data to knowledgeable audiences, with limited supervision.
✓Demonstrates change Agility through willingness to pivot current ways to working to new model(s)
✓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.
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✓Innovates to bring solutions that impact CBI level or higher
✓Basic understanding of clinical and biomedical research, GCP, GLP, CLIA, data management, risk management, and regulatory issues.
✓3+ years academic, biotech, healthcare or pharmaceutical industry experience or equivalent

Education/Experience/ Licenses/Certifications

✓Scientific degree (Associates, Bachelors, Masters, or higher), Project management or equivalent experience.

Travel

Travel required is minimal, 0%- 5% of time, when organization requests

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

Warsaw - PL: zł194,000 - zł235,087

The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience.

The final compensation will be determined based on demonstrated experience and in accordance with pay equity principles and applicable employment laws.

Manager II Biospecimen Lead