Associate Director, Companion Diagnostics & Bioanalysis

Bristol Myers Squibb

4d • Hybrid

About The Position

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 GMP principles when program needs require it. The incumbent will wire in quality from the start, embedding QMSR/820 design controls, CLIA/CAP, IVDR, ISO13485, 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.

Requirements

• 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.
• Expertise in IHC (primary focus), with experience in NGS, PCR, and flow cytometry.
• Strong knowledge of FDA QSMR, GLP, CLIA, CAP, ISO13485, IVDR, and ICH-GCP.
• Experience with LIMS and electronic data management systems, ensuring compliance with GDP and ALCOA principles.
• Proven ability to manage complex projects, vendors, and cross-functional teams.

Nice To Haves

• 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 ISO13485 requirements.
• PMP certification or equivalent preferred.

Responsibilities

• 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, ISO13485, CLIA/CAP throughout operations; maintain inspection-ready execution.
• Operationalize Good Documentation Practices (GDP) and ALCOA/ALCOA+ across sample, method, and data lifecycles; 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.

Benefits

• Health Coverage: Medical, pharmacy, dental, and vision care.
• Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
• Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
• Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays Based on eligibility, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.
• All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees