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.

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Position Summary

The Associate Director, Companion Diagnostics & Bioanalysis provides scientific, strategic, and operational leadership for the planning, development, validation, and execution of clinical and translational diagnostic assays in support of precision medicine and companion diagnostics (CDx) programs. The role operates within CLIA- and GxP-regulated laboratory environments and partners cross-functionally with Clinical Operations, Translational Medicine, Biomarkers, Regulatory Affairs, Quality, and external diagnostic partners to deliver compliant, high-quality diagnostic solutions aligned with clinical development timelines and regulatory expectations.

Key Responsibilities:

• Provide scientific and operational leadership for IHC and molecular diagnostic assay platforms supporting translational research and clinical development programs.

• Define and execute diagnostic and bioanalysis strategies across early- and late-stage clinical programs, including companion diagnostic enablement.

• Lead assay development, validation, qualification, technology transfer, and lifecycle management activities within CLIA- and GxP-regulated laboratory environments.

• Serve as a subject matter expert for molecular diagnostics (qPCR, ddPCR, NGS), IHC, and flow cytometry–based assays.

• Partner with Clinical Operations, Translational Medicine, Biomarkers, Program Management, Regulatory Affairs, and Quality to ensure alignment with protocol, regulatory, and operational requirements.

• Oversee and manage external vendors, CROs, and diagnostic partners, including scope definition, performance oversight, risk management, issue resolution, and budget accountability.

• Contribute to governance forums, risk assessments, and decision-making bodies related to diagnostic strategy, execution, and vendor selection.

• Support inspection readiness and participate in internal and external audits, including regulatory inspections and partner audits.

• Provide people leadership through mentoring, coaching, and development of scientific and operational talent, fostering a culture aligned with BMS values of integrity, inclusion, accountability, urgency, and innovation.

Qualifications & Experience:

• 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.

• Experience supporting oncology-focused precision medicine or companion diagnostic programs.

• Prior experience working within or partnering with CLIA-certified laboratories.

• Background in pharmaceutical, biotechnology, or diagnostic industry environments.

• Experience engaging with global diagnostic platform providers (e.g., molecular, IHC, NGS, or flow cytometry technologies).

• Recognized leader in IHC and molecular diagnostic assay platforms, including qPCR, ddPCR, and Next‑Generation Sequencing (NGS), with applied expertise in flow cytometry across translational and clinical diagnostic settings.

• Accountable for end‑to‑end assay strategy, development, validation, and lifecycle management within CLIA‑ and GxP‑regulated laboratories, enabling precision medicine and companion diagnostic programs across clinical development.

• Strong working knowledge of applicable regulatory and quality requirements, including CLIA, GCP, GLP, and relevant FDA and global regulations.

• Demonstrated ability to lead complex, cross-functional initiatives and influence stakeholders in a h