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.

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, MD, PharmD, MS
• Experience Requirements: Significant experience in regulatory affairs and diagnostic-related development (8‚Äì10+ years)
• Key Competency Requirements:
  • Scientific & Diagnostic Expertise: Deep expertise in global diagnostic development with proficiency in IHC, NGS, PCR, and/or mass spectrometry.
  • Biomarker & CDx Strategy: Experience in regulatory strategies for companion diagnostics and biomarkers, including analytical validation, clinical development, manufacturing, and global regulatory submissions.
  • Regulatory Leadership & Strategic Planning: Proven ability to lead teams through health authority interactions and develop global regulatory strategies across drug and device development.
  • Regulatory Standards Mastery: Knowledge of 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: Ability to translate complex concepts for leadership and cross-functional teams; strong partnerships in matrixed environments.
  • Influence & Decision Making: Accountability, facilitation, negotiation, and strategic influence to balance innovation and compliance.
  • Inclusive Leadership & Continuous Improvement: Values diverse perspectives and fosters continuous improvement.

Skills

• Global diagnostic development, regulatory strategy, health authority engagement
• Investigation of regulatory frameworks for investigational assays
• Strategic planning, policy review, and cross-functional leadership
• Communication of complex scientific/regulatory concepts to senior leaders

Education

• PhD or MD or PharmD or MS with strong scientific background

Additional Requirements

• Travel: Up to 20%