Associate Director, Companion Diagnostics & Bioanalysis

Working with Us

Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it.

You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more:

At Bristol Myers Squibb, our work is guided by a singular purpose: deliver better outcomes for patients, faster. This role leads the planning and operational execution of regulated laboratory activities that enable precision medicine, with a major focus on Companion Diagnostics (CDx) design control, validation, and clinical enablement, and the agility to pivot to GLP bioanalysis (PK/PD/ADA) under GxP principles when program needs require it.

The incumbent will wire in quality from the start, embedding QMSR/820 design controls, CLIA/CAP, IVDR, ISO
13485, and 21 CFR 11 across lab operations, data, and vendor ecosystems - so we are inspection-ready, compliant, and outcomes-driven for patients. The role partners closely with Translational Medicine, Clinical Development, Regulatory/QA, Finance/Legal, and external CRO/IVD partners to shorten cycle times, de-risk trials, and improve patient selection and access to the right therapy.

• Lead operational delivery of CLIA-based CDx initiatives: support design input/output, analytical validation, tech transfer, and clinical deployment across IHC and complementary platforms (NGS, PCR, flow cytometry).
• Drive design control rigor (risk management, traceability, DMR/DHR readiness) and partner with Regulatory/QA on submissions and audits.
• Integrate diagnostic strategies into clinical protocols to improve patient stratification and outcomes.
• Coordinate GLP-compliant bioanalytical programs (PK/PD/ADA) supporting clinical studies; oversee assay timelines, critical reagents, data transfers, and CRO deliverables.
• Ensure readiness for IND/IDE/PMA/510(k) touchpoints in partnership with Regulatory/QA.
• Embed FDA QMSR/21 CFR 820, 21 CFR 11, EU IVDR, ISO
  13485, CLIA/CAP throughout operations; maintain inspection-ready execution.
• Operationalize Good Documentation Practices (GDP) and ALCOA/ALCOA+ across sample, method, and data life cycles; steward validated LIMS/ELN records and audit trails.
• Serve as the primary liaison for CROs, central labs, IVD/CDx manufacturers, and specialty vendors: define scopes, SLAs, issue management, and quality/compliance expectations; ensure timely, patient-impacting delivery.
• Build transparent plans and own outcomes across scope, timeline, risk, and budget; forecast resources and shape capital investments in enabling platforms.
• Provide concise, patient-oriented updates to leadership; escalate risks early with data-backed mitigations.
• Model the BMS Behaviors—Urgency & Agility, Accountability, Innovation, and Passion for Excellence & Integrity—to create an inclusive, high-trust environment that delivers for patients.
• Rewiring BMS: simplify interfaces, remove waste, and leverage AI-enabled, data-driven workflows to accelerate impact and decision-making in line with the enterprise change narrative.

• Bachelor’s degree in scientific/engineering discipline required; MS/Ph.D. preferred.
• 8+ years in GxP-regulated environments, including CDx/IVD development and bioanalysis in pharma, biotech, or CRO settings.
• Preferred:
  Previous experience at world-class diagnostic manufacturers in technology areas such as IHC, NGS, PCR, and flow cytometry, working under FDA QSMR (21 CFR Part 820), 21 CFR Part 11, EU IVDR, and ISO
  13485 requirements.
• Expertise…