CBI - Biospecimen Lead (BSL)

Bristol Myers Squibb; Warszawa; On-site; PLN 219,000 - 265,000; Full time

Job summary

Bristol Myers Squibb in Warsaw seeks a Manager, Biospecimen Lead to work with Clinical Teams to develop and implement biospecimen management plans for BMS-sponsored trials from Phase 1-4. You will engage cross-functionally to operationalize the plan and provide updates on sample status.

The role requires delivering timelines for data delivery, enabling timely decisions, and contributing to process improvements across workflows with innovative technologies.

Qualifications

• Experience with biospecimen procedures and lifecycle management.
• Vendor experience with labs, CROs, and storage providers.
• Ability to resolve complex problems and make data-driven decisions.
• Able to train and mentor new colleagues.
• Strong communication and data-management skills.
• Demonstrates inclusion and collaboration across teams.

Responsibilities

• Oversee biospecimen management in 5-12 clinical trials.
• Develop and maintain the Specimen Management Plan.
• Provide biospecimen input in protocol authoring for feasibility and compliance.
• Track and reconcile biospecimen status across systems.
• Coordinate biospecimen requirements with contracting and vendor docs.
• Provide regular biospecimen status updates to the core clinical team.
• Adhere to SOPs and guidance documents.
• Act as liaison between clinical teams and vendors to resolve issues.
• Participate in vendor audits and CAPA resolutions.
• Maintain study documents in inspection-ready state.
• Contribute to cross-functional projects to optimize workflows.
• Mentor and train new colleagues.
• Maintain knowledge of therapeutic areas and study biospecimen requirements.

Skills

Biospecimen handling

Vendor management

Decision making

Communication

Training others

Cross-functional collaboration

Education

Scientific degree

Tools

LIMS

Job description

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/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.
• undefined
• 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.
• undefined
• 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.
• 4+ 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

Compensation Overview

Warsaw - PL: zł218,900 - zł265,225

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.

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 [e-mail]. 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.

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.