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

Senior 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 and externally acquired biospecimens. Will develop and execute asset and protocol-level biospecimen strategies and work across the organization and with BMS’s partners to implement and project manage efforts to execute these strategies.

Critical to this role is the ability to provide innovative 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 assets with opportunities to contribute toward optimizing work streams cross functionally throughout the organization as it relates to biospecimens

Duties/Responsibilities

Oversee and manage the complete lifecycle of biospecimens (collection, storage, use, and final disposition) for clinical studies with minimal to no supervision.

Core Clinical Team member responsible for creating the Specimen Management Plan and facilitates discussions to operationalize strategy.

Providing Shipping/sample movement and management including requests, query and inventory reports, follow up active issues with vendors, prepare sample management related reports, review/prepare tracking activities (such as vendor manifests/inventories, tissue/blood match pairing, depleted/non-viable samples, loading documents to Shared Drive folders, etc.).

Independently reviews clinical study protocol providing comparison of vendor statement of work and biospecimen relevant sections and provide feedback.

Performs routine vendor management responsibilities. Able to request and/or access necessary vendor/system inventory files to perform specimen tracking with minimal Data Integration with enrollment and vendor specimen inventory.

Able to create biospecimen tracker using various tracking tools (MS Excel, Spotfire, Tableau or Polaris (if applicable)) with minimal support.

Able to identify biospecimen related risks with support from risk library as well as de novo. Manage Critical to Quality (C2Q) processes with clinical teams.  Can identify and resolve vendor related issues in addition to vendor management responsibilities.

Exercises judgment within policy and procedure boundaries. Troubleshoots routine problems and provide mitigation proposals to stakeholders.  Prioritize BOW activities during critical deadlines with little or no supervision.

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.
• Demonstrated clinical trial experience, healthcare/medical/laboratory or equivalent. Has developed Knowledge of the drug discovery or development process.
• 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.
• Ability to display skills for stakeholder management including conflict and change management.
• Actively participates and demonstrates the ability to independently manage projects and initiatives in addition to assigned BOW.
• Serves as SME/coach for junior staff to autonomously support trials.
• Plans, directs, and executes functional area processes for protocol related activities.
• Key participant in cross functional team meetings. Effectively communicate, 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.
• Identifies issues and suggests solutions.
• Acts as CBI and GDO "ambassador" by exhibiting general knowledge of other GDO departments and responsibilities and willingly educates stakeholders.
• Minimum of 5-6 years academic, biotech, healthcare or pharmaceutical industry experience.
• Solid understanding of clinical and biomedical research including aspects such as: GCP, GLP, CLIA, data management, risk management, and regulatory issues.
• Experience preferred but not limited to: biospecimen life-cycle/operations, biospecimen result and data flows, compliance, management, and vendor management.
• 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.