Director, Early Precision Medicine Regulatory Affairs

Role Summary

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.

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

Qualifications

• Degree Requirements: Solid scientific background, PhD., M.D., PharmD, MS
• Significant experience in regulatory affairs and diagnostic-related development e.g., >8-10 years
• Scientific & Diagnostic Expertise: Deep expertise in global diagnostic development-including US, EU, Canada, Australia, Japan, China submissions, etc.-with proficiency in IHC, NGS, PCR, and/or mass spectrometry, spanning assay design through regulatory approval
• Biomarker & CDx Strategy: 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
• Regulatory Leadership & Strategic Planning
• Proven ability to lead teams through complex health authority interactions and issue resolution, with deep expertise in developing and executing global regulatory strategies across drug and device development
• Regulatory Standards Mastery: GCP, GLP, CLIA, HIPAA, 21 CFR Parts 11, 312, 812, 820, ISO 13485, ISO 14971, EU IVDR, CMDR, TGA, PMDA, NMPA, ICH guidelines
• Communication & Collaboration: Skilled in translating complex scientific and regulatory concepts into clear insights for senior leadership and cross-functional teams; strong partnerships in matrixed environments
• Influence & Decision Making: Demonstrates accountability and strategic influence; capable of leading teams to timely, high-quality regulatory decisions balancing innovation, compliance, and enterprise impact
• Inclusive Leadership & Continuous Improvement: Values diverse perspectives and continuous improvement
• Travel: Up to 20%

Additional Requirements

• Travel Up to 20%