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
Job 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.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment and offers a wide variety of competitive benefits, services and programs.
Matching 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.
Salary
Base: $244,110 - $295,806 (Cambridge Crossing); $217,960 - $264,113 (Princeton - NJ - US); Bonus/Equity: Additional incentive cash and stock opportunities may be available; Benefits: Health Coverage, Wellbeing Support, Financial Well-being and Protection, Work-life benefits
Skills & Requirements
Must-have
Global regulatory strategy for biomarkers
Early-stage development through proof of concept
Investigational assay development frameworks
Drug-diagnostic strategies
Health authority engagement
Precision medicine regulatory expertise
Nice-to-have
Cross-functional leadership
Commitment to innovation
Translational Medicine CLIA Laboratory Steering Committee
Policy shaping through trade association engagement
Key Requirements
PhD., M.D., PharmD, MS degree
>8-10 years regulatory affairs and diagnostic development
Deep expertise in global diagnostic development
Extensive experience in biomarker and CDx strategy
Proven ability to lead teams through complex health authority interactions
Mastery of regulatory standards (GCP, GLP, CLIA, HIPAA, 21 CFR Parts, ISO, EU IVDR, CMDR, TGA, PMDA, NMPA, ICH)