Director, Early Precision Medicine Regulatory Affairs

Overview

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.

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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—enhancing the impact and value of our medicines across therapeutic areas.
• Design and operationalize a scalable regulatory framework within BMS that supports 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…