Director, Early Precision Medicine Regulatory Affairs

Bristol Myers Squibb•Princeton, NJ

46d•$217,960 - $295,806•Hybrid

About The Position

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.

Requirements

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, but not limited to key markets such as US, EU, Canada, Australia, Japan, China submissions, etc.-with preferred subject matter proficiency in IHC, NGS, PCR, and/or mass spectrometry, spanning assay design through regulatory approval.
Extensive experience in designing regulatory strategies for companion diagnostics and biomarkers, with deep expertise in assay and IVD development-including analytical validation, clinical development, manufacturing, and global regulatory submissions through commercialization.
Proven ability to lead teams through complex health authority interactions and issue resolution, paired with deep expertise in developing and executing global regulatory strategies across drug and device development.
Regulatory Standards Mastery, but not limited to GCP, GLP, CLIA, HIPAA, 21 CFR Parts 11, 312, 812, 820, ISO 13485, ISO 14971, EU IVDR, CMDR, TGA, PMDA, NMPA, and ICH guidelines to ensure compliance and quality across investigational use only assay programs.
Skilled in translating complex scientific and regulatory concepts into clear, actionable insights for senior leadership and cross-functional teams. Builds strong partnerships across internal and external stakeholders in matrixed environments to drive alignment and shared success.
Demonstrates high personal accountability and excels in facilitation, negotiation, and strategic influence. Proven ability to lead teams in making timely, high-quality regulatory decisions that balance innovation, compliance, and enterprise impact.
Values diverse perspectives, fosters a culture of continuous improvement, and encourages open dialogue on risks, issues, and successes.
Travel: Up to 20%

Responsibilities

Drive the development and actively support the execution of innovative, compliant global regulatory strategies that enable cutting-edge biomarkers and diagnostic tests-enhancing the impact and value of our medicines across therapeutic areas.
Design and operationalize a scalable regulatory framework within BMS that supports both internal investigational assay development and clinical specimen testing, while overseeing external investigational use only assay development-ensuring strategic alignment with business needs and enabling timely, compliant submissions
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 for patient selection and stratification in BMS Phase I/II studies-enabling business agility and advancing our commitment to precision medicine by ensuring the right drug reaches the right patient at the right time.
Champion innovative regulatory strategies to resolve complex challenges and accelerate patient access, while ensuring early integration of precision medicine approaches-including coordination of key regulatory and clinical documents to support drug and diagnostic submissions, proactive health authority engagement, and robust risk mitigation planning.
Cultivate inclusive, high-impact collaboration with Precision Medicine, Research teams, Global and Regional Regulatory Leads, Global Regulatory Operations, and Quality by delivering timely, strategic guidance in health authority engagements and policy review-ensuring diverse expertise is integrated to drive precision medicine innovation.
Oversee global precision medicine submissions and health authority interactions-including PSAs, SRD, Pre-subs, IDEs, including international related submissions for investigational use only assay in clinical studies-in partnership with the Precision Medicine Lead
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 and maintaining deep awareness of scientific, competitive, and diagnostic industry trends-acting as a trusted resource for institutional knowledge and informing precision medicine decision-making across BMS.
Engages with stakeholders on a regular basis to better understand organization needs and risk areas and identify pragmatic impactful solutions

Benefits

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, business travel protection and survivor support.
Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility.
Parental, caregiver, bereavement, and military leave.
Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources.
Other perks like tuition reimbursement and a recognition program.

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