Director, Early Precision Medicine Regulatory Affairs

Bristol Myers Squibb-posted 3 months ago

$217,960 - $264,113/Yr

Full-time • Senior

Princeton, NJ

5,001-10,000 employees

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The Director of Early Precision Medicine Regulatory Affairs leads global regulatory strategy for biomarkers and diagnostics, focusing on early-stage development through proof of concept and supporting registrations. This role establishes scalable frameworks for investigational assay development, ensuring timely, compliant submissions that support patient stratification in Phase I/II studies. As a key member of the Translational Medicine CLIA Laboratory Steering Committee, the director drives coordinated early-stage drug-diagnostic strategies and health authority engagement to accelerate access to precision therapies. The position demands deep scientific and regulatory expertise (US, EU, Canada, PMD, TGA or Global Devices/IVD preferred), cross-functional leadership, and a commitment to innovation in early precision medicine.

Drive the development and actively support the execution of innovative, compliant global regulatory strategies that enable cutting-edge biomarkers and diagnostic tests.
Design and operationalize a scalable regulatory framework within BMS that supports both internal investigational assay development and clinical specimen testing.
Serve as the regulatory lead on the Translational Medicine CLIA Laboratory Steering Committee, providing strategic guidance and hands-on execution in the design, development, and testing of investigational use assays.
Champion innovative regulatory strategies to resolve complex challenges and accelerate patient access.
Cultivate inclusive, high-impact collaboration with Precision Medicine, Research teams, Global and Regional Regulatory Leads, Global Regulatory Operations, and Quality.
Oversee global precision medicine submissions and health authority interactions.
Provide regulatory support on product partnership, vendor management and business development opportunities.
Serve as a strategic regulatory thought leader by actively shaping policy through trade association engagement.

Solid scientific background, PhD., M.D., PharmD, MS.
Significant experience in regulatory affairs and diagnostic-related development e.g., >8-10 years.
Deep expertise in global diagnostic development, including key markets such as US, EU, Canada, Australia, Japan, China submissions.
Extensive experience in designing regulatory strategies for companion diagnostics and biomarkers.
Proven ability to lead teams through complex health authority interactions and issue resolution.
Mastery of regulatory standards including GCP, GLP, CLIA, HIPAA, 21 CFR Parts 11, 312, 812, 820, ISO 13485, ISO 14971, EU IVDR, CMDR, TGA, PMDA, NMPA, and ICH guidelines.
Skilled in translating complex scientific and regulatory concepts into clear, actionable insights.
Demonstrates high personal accountability and excels in facilitation, negotiation, and strategic influence.

Experience with IHC, NGS, PCR, and/or mass spectrometry.
Experience in assay design through regulatory approval.

Medical, pharmacy, dental and vision care.
Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP).
Financial well-being resources and a 401(K).
Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance.
Work-life programs including paid national holidays and optional holidays, Global Shutdown Days, up to 120 hours of paid vacation.
Parental, caregiver, bereavement, and military leave.
Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits.
Tuition reimbursement and a recognition program.

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