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

Position Summary

The Associate Director, Project Management & Operations (PM&O) leads the program management and operational framework supporting BMS’s internal CLIA laboratory and Bioanalysis Biotherapeutics & Cell Therapy programs. This role enables internal and external bioanalysis studies and supports the development, verification, validation, and transfer of investigational biomarker assays used in early-stage Phase I/II patient stratification studies. The Associate Director brings systems engineering, design control, and operational rigor to regulated laboratory and assay programs, including alignment with FDA 21 CFR 820 (QSR), EU IVDR, ISO 13485, CLIA, GLP, and GCP requirements. The role partners closely with Translational Medicine, Clinical Pharmacology, Precision Medicine, Program Management, Regulatory Affairs, Quality, and Clinical Operations to translate complex cross-functional programs into on-time, on-budget, and audit-ready results. The successful candidate will demonstrate strong ownership and accountability, clear communication, disciplined risk management, financial and operational acumen, and the ability to lead complex programs across a highly matrixed organization.

Key Responsibilities

• Serve as process lead for assay and biomarker design, development, validation, qualification, and technology transfer, driving project plans, timelines, resourcing, and cross-functional execution across internal and external Bioanalysis Biotherapeutics & Cell Therapy programs and early-stage Phase I/II patient stratification studies.
• Drive design control practices 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 (V&V), 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, Next-Generation Sequencing (NGS), and Bioanalysis Biotherapeutics & Cell Therapy biomarker programs.
• Own program planning, timelines, resource management, and CapEx/OpEx budgets for internal BMS CLIA laboratory and Bioanalysis Biotherapeutics & Cell Therapy operations, including project intake and governance.
• Partner with Precision Medicine, Clinical Pharmacology, Translational Medicine, Program Management, Regulatory Affairs, Quality, and Clinical Operations to ensure alignment with clinical protocols, regulatory requirements, and operational priorities.
• Lead third-party risk management (TPRM) and supplier quality management (SQM) for external vendors, CROs, and assay and biomarker partners, including scope definition, contracting, performance oversight, issue resolution, compliance, and budget accountability.
• Strengthen program and laboratory compliance with applicable GLP, GCP, CLIA, CAP, and other regulatory requirements and lead inspection readiness for internal and external audits, State inspections, CAP/CLIA inspections, and Health Authority inspections.
• Represent PM&O on governance and steering committees supporting the internal BMS CLIA laboratory and Bioanalysis Biotherapeutics & Cell Therapy programs, driving risk assessments, vendor selection, and strategic decision-making.
• Own systems, processes, and reporting for key laboratory operational and compliance metrics, including turnaround time, pricing, Electronic Lab Notebook (ELN) usage, equipment calibration and maintenance, temperature monitoring, and LIMS/data management.
• Proactively identify, assess, mitigate, and escalate risks across laboratory operations, assay programs, external partnerships, timelines, quality, budget, and compliance.

Qualifications & Experience

• Bachelor’s degree in a scientific or engineering discipline required; MS or Ph.D. preferred.
• Minimum of 8 years of combined laboratory operations and program/project management experience within the pharmaceutical, biotechnology, diagnostics, or related regulated industry.
• Experience working within or overseeing CLIA-certified and/or GxP-regulated laboratory environments, including equipment compliance, resource and capacity planning, laboratory operations, and audit readiness.
• Deep 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 (V&V), 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.
• Experience within an IHC or molecular diagnostic manufacturer, PCR/NGS manufacturing organization, or comparable regulated device/IVD environment strongly preferred.
• Demonstrated understanding of GLP, GCP, CLIA, CAP, and other applicable regulatory and compliance requirements, with experience maintaining inspection- and audit-ready programs.
• Proven ability to lead complex, cross-functional programs and influence stakeholders across Translational Medicine, Clinical Pharmacology, Precision Medicine, Program Management, Regulatory Affairs, Quality, Clinical Operations, or comparable functions.
• Strong ownership and accountability for program outcomes, with demonstrated ability to independently manage timelines, quality, deliverables, and competing priorities in a fast-paced, matrixed environment.
• Strong written and verbal communication skills, including the 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.
• Strong understanding of project financial management, including budgeting, expenditures, CapEx/OpEx planning, contract development, and identification of cost efficiencies.
• Demonstrated 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.
• PMP certification preferred.
• Occasional travel may be required to support laboratory, CRO, and vendor oversight.