Director, Early Precision Medicine Regulatory Affairs
Bristol Myers Squibb
2 hours ago
Remote friendly (San Diego Metropolitan Area)
United States
Corporate Functions
Position 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. Establishes scalable frameworks for investigational assay development to enable timely, compliant submissions supporting patient stratification in Phase I/II studies. Serves as a key member of the Translational Medicine CLIA Laboratory Steering Committee to drive coordinated early-stage drug-diagnostic strategies and health authority engagement.
Key Responsibilities
- Drive development and execution of innovative, compliant global regulatory strategies for biomarkers and diagnostic tests.
- Design and operationalize a scalable regulatory framework supporting internal investigational assay development and clinical specimen testing; oversee external investigational use-only assay development to ensure alignment, timeliness, and compliance.
- Act as regulatory lead on the Translational Medicine CLIA Laboratory Steering Committee for design, development, and testing of investigational use assays for patient selection and stratification in BMS Phase I/II studies.
- Champion regulatory strategies to resolve complex challenges and accelerate patient access; ensure early integration of precision medicine approaches, including coordination of regulatory/clinical documents, proactive health authority engagement, and risk mitigation.
- Lead inclusive, cross-functional collaboration with Precision Medicine, Research, Global/Regional Regulatory Leads, Global Regulatory Operations, and Quality; provide timely guidance for health authority engagement and policy review.
- Oversee global precision medicine submissions and health authority interactions (e.g., PSAs, SRD, Pre-subs, IDEs), including international submissions for investigational use-only assays in clinical studies.
- Provide regulatory support for product partnerships, vendor management, and business development opportunities.
- Shape policy through trade association engagement and maintain awareness of scientific/competitive/diagnostic industry trends.
- Engage with stakeholders to understand organizational needs and risk areas and identify practical solutions.
Qualifications & Experience
- Solid scientific background: PhD, M.D., PharmD, or MS.
- >8–10 years of regulatory affairs and diagnostic-related development experience.
- Expertise in global diagnostic development, including IHC, NGS, PCR, and/or mass spectrometry; experience across key markets (US, EU, Canada, Australia, Japan, China, etc.).
- Extensive experience designing regulatory strategies for companion diagnostics and biomarkers; deep expertise across assay/IVD development (analytical validation, clinical development, manufacturing) and global regulatory submissions through commercialization.
- Proven ability to lead teams through complex health authority interactions and issue resolution.
- Mastery of regulatory standards and guidelines, including GCP, GLP, CLIA, HIPAA, 21 CFR Parts 11/312/812/820, ISO 13485, ISO 14971, EU IVDR, CMDR, TGA, PMDA, NMPA, and ICH guidelines.
- Strong communication and collaboration skills; ability to translate complex scientific/regulatory concepts into actionable insights.
- Demonstrated accountability, facilitation, negotiation, and strategic influence.
Preferred Skills/Expertise
- Deep scientific and regulatory expertise in US, EU, Canada, PMD, TGA, or Global Devices/IVD.
Benefits (explicitly stated)
- Health Coverage: Medical, pharmacy, dental, and vision care.
- Wellbeing Support Programs (e.g., BMS Well-Being Account, BMS Living Life Better, EAP).
- Financial Well-being and Protection: 401(k), short-/long-term disability, life and accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, survivor support.
- Work-life benefits: Paid Time Off (including flexible time off/annual paid vacation details as described).
Application Instructions
- If you come across a role that intrigues you but doesn't perfectly line up with your resume, you are encouraged to apply anyway.
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. Establishes scalable frameworks for investigational assay development to enable timely, compliant submissions supporting patient stratification in Phase I/II studies. Serves as a key member of the Translational Medicine CLIA Laboratory Steering Committee to drive coordinated early-stage drug-diagnostic strategies and health authority engagement.
Key Responsibilities
- Drive development and execution of innovative, compliant global regulatory strategies for biomarkers and diagnostic tests.
- Design and operationalize a scalable regulatory framework supporting internal investigational assay development and clinical specimen testing; oversee external investigational use-only assay development to ensure alignment, timeliness, and compliance.
- Act as regulatory lead on the Translational Medicine CLIA Laboratory Steering Committee for design, development, and testing of investigational use assays for patient selection and stratification in BMS Phase I/II studies.
- Champion regulatory strategies to resolve complex challenges and accelerate patient access; ensure early integration of precision medicine approaches, including coordination of regulatory/clinical documents, proactive health authority engagement, and risk mitigation.
- Lead inclusive, cross-functional collaboration with Precision Medicine, Research, Global/Regional Regulatory Leads, Global Regulatory Operations, and Quality; provide timely guidance for health authority engagement and policy review.
- Oversee global precision medicine submissions and health authority interactions (e.g., PSAs, SRD, Pre-subs, IDEs), including international submissions for investigational use-only assays in clinical studies.
- Provide regulatory support for product partnerships, vendor management, and business development opportunities.
- Shape policy through trade association engagement and maintain awareness of scientific/competitive/diagnostic industry trends.
- Engage with stakeholders to understand organizational needs and risk areas and identify practical solutions.
Qualifications & Experience
- Solid scientific background: PhD, M.D., PharmD, or MS.
- >8–10 years of regulatory affairs and diagnostic-related development experience.
- Expertise in global diagnostic development, including IHC, NGS, PCR, and/or mass spectrometry; experience across key markets (US, EU, Canada, Australia, Japan, China, etc.).
- Extensive experience designing regulatory strategies for companion diagnostics and biomarkers; deep expertise across assay/IVD development (analytical validation, clinical development, manufacturing) and global regulatory submissions through commercialization.
- Proven ability to lead teams through complex health authority interactions and issue resolution.
- Mastery of regulatory standards and guidelines, including GCP, GLP, CLIA, HIPAA, 21 CFR Parts 11/312/812/820, ISO 13485, ISO 14971, EU IVDR, CMDR, TGA, PMDA, NMPA, and ICH guidelines.
- Strong communication and collaboration skills; ability to translate complex scientific/regulatory concepts into actionable insights.
- Demonstrated accountability, facilitation, negotiation, and strategic influence.
Preferred Skills/Expertise
- Deep scientific and regulatory expertise in US, EU, Canada, PMD, TGA, or Global Devices/IVD.
Benefits (explicitly stated)
- Health Coverage: Medical, pharmacy, dental, and vision care.
- Wellbeing Support Programs (e.g., BMS Well-Being Account, BMS Living Life Better, EAP).
- Financial Well-being and Protection: 401(k), short-/long-term disability, life and accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, survivor support.
- Work-life benefits: Paid Time Off (including flexible time off/annual paid vacation details as described).
Application Instructions
- If you come across a role that intrigues you but doesn't perfectly line up with your resume, you are encouraged to apply anyway.