Associate Director, Project Management & Operations – (Translational Medicine, CLIA, & Bioanalysis)

Bristol Myers Squibb • Princeton, NJ

20h • $156,890 - $190,117 • Hybrid

About The Position

The Associate Director, Project Management & Operations leads the program management and operational framework supporting BMS’s internal CLIA laboratory and Bioanalysis Biotherapeutics & Cell Therapy programs. The role enables internal and external bioanalysis studies and supports development, verification, validation, and transfer of investigational biomarker assays used in early-stage Phase I/II patient stratification studies.

The position applies systems engineering, design control, and operational rigor to regulated laboratory and assay programs, aligning work with FDA 21 CFR 820 (QSR), EU IVDR, ISO 13485, CLIA, GLP, and GCP requirements. It partners with Translational Medicine, Clinical Pharmacology, Precision Medicine, Program Management, Regulatory Affairs, Quality, and Clinical Operations to deliver cross-functional programs on time, within budget, and in an audit-ready state.

The successful candidate demonstrates ownership, accountability, clear communication, disciplined risk management, financial and operational acumen, and the ability to lead complex programs across a highly matrixed organization. Occasional travel may be required to support laboratory, CRO, and vendor oversight.

Requirements

• Bachelor’s degree in a scientific or engineering discipline.
• At least 8 years of combined laboratory operations and program/project management experience in pharmaceutical, biotechnology, diagnostics, or a related regulated industry.
• Experience working within or overseeing CLIA-certified and/or GxP-regulated laboratories, including equipment compliance, resource and capacity planning, laboratory operations, and audit readiness.
• Knowledge of design control and systems engineering principles aligned with FDA 21 CFR 820 (QSR), EU IVDR, and ISO 13485, including design inputs/outputs, verification and validation, risk management, and design transfer to production.
• Experience applying design control principles to investigational assays, early-stage Phase I/II assay development, and/or IVD device development.
• Experience with IHC and/or molecular diagnostic technologies such as qPCR, ddPCR, PCR, or NGS.
• Understanding of GLP, GCP, CLIA, CAP, and other applicable regulatory and compliance requirements, with experience maintaining inspection- and audit-ready programs.
• Ability to lead complex cross-functional programs and influence stakeholders across relevant scientific, clinical, operational, regulatory, and quality functions.
• Ability to independently manage timelines, quality, deliverables, and competing priorities in a fast-paced, matrixed environment, with strong ownership and accountability.
• Strong written and verbal communication skills, including ability to translate complex scientific, technical, operational, and regulatory information into clear recommendations for senior leadership.
• Experience managing external vendors, CROs, and diagnostic partners through formal TPRM and SQM processes, including contracting, performance oversight, compliance accountability, and issue resolution.
• Understanding of project financial management, including budgeting, expenditures, CapEx/OpEx planning, contract development, and cost efficiencies.
• Ability to proactively identify and mitigate operational, technical, financial, vendor, and compliance risks.
• Proficiency with project management and information technology systems such as Microsoft Office, Project, Excel, Teams, Visio, SAP, Ariba, and LIMS.

Nice To Haves

• Master’s degree or Ph.D.
• Experience within an IHC or molecular diagnostic manufacturer, PCR/NGS manufacturing organization, or comparable regulated device/IVD environment.
• PMP certification.

Responsibilities

• Lead assay and biomarker design, development, validation, qualification, and technology transfer; manage project plans, timelines, resourcing, and cross-functional execution for internal and external programs and early-stage Phase I/II patient stratification studies.
• Drive design control across the assay lifecycle in accordance with FDA 21 CFR 820 (QSR), EU IVDR, and ISO 13485, including systems engineering, design inputs and outputs, verification and validation, risk management, and design transfer to production.
• Lead project and program management for internal IHC and molecular investigational use only (IUO) assay programs, including qPCR, ddPCR, and NGS, as well as Bioanalysis Biotherapeutics & Cell Therapy biomarker programs.
• Own program planning, timelines, resource management, CapEx/OpEx budgets, project intake, and governance for internal BMS CLIA laboratory and Bioanalysis Biotherapeutics & Cell Therapy operations.
• Partner with relevant cross-functional groups to ensure alignment with clinical protocols, regulatory requirements, and operational priorities.
• Lead third-party risk management and supplier quality management for external vendors, CROs, and assay and biomarker partners, including scope definition, contracting, performance oversight, issue resolution, compliance, and budget accountability.
• Strengthen compliance with applicable GLP, GCP, CLIA, CAP, and other regulatory requirements, and lead readiness for internal and external audits, State inspections, CAP/CLIA inspections, and Health Authority inspections.
• Represent PM&O on governance and steering committees, driving risk assessments, vendor selection, and strategic decision-making.
• Own systems, processes, and reporting for laboratory operational and compliance metrics, including turnaround time, pricing, ELN usage, equipment calibration and maintenance, temperature monitoring, and LIMS/data management.
• Identify, assess, mitigate, and escalate risks relating to laboratory operations, assay programs, external partnerships, timelines, quality, budget, and compliance.

Benefits

• Comprehensive benefit plans, including wellbeing support, retirement and financial protection benefits, and medical, dental, vision, life, and disability insurance offerings, subject to plan terms and eligibility.
• Flexible Time Off (FTO) for eligible U.S.-based exempt employees, subject to manager approval.
• For applicable employee groups, 160 hours of paid vacation annually for new hires, subject to manager approval.
• 11 paid company holidays; certain employee groups also receive 3 optional holidays.
• Depending on eligibility, paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs.
• Eligible employees may receive an annual Global Shutdown between Christmas Day and New Year's Day.
• Potential eligibility for discretionary incentive cash and stock opportunities.

What This Job Offers

• Job Type: Full-time
• Career Level: Director