Director, Early Precision Medicine Regulatory Affairs
Bristol Myers Squibb
12 hours ago
Remote friendly (Princeton, NJ)
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.
Key Responsibilities
- Drive development and execution of innovative, compliant global regulatory strategies for biomarkers and diagnostic tests across therapeutic areas.
- Design and operationalize a scalable regulatory framework supporting internal investigational assay development and clinical specimen testing; oversee external investigational use-only assay development to enable timely, compliant submissions.
- Serve as regulatory lead on the Translational Medicine CLIA Laboratory Steering Committee; provide strategic guidance and hands-on execution for investigational use assays for patient selection/stratification in BMS Phase I/II studies.
- Champion regulatory strategies to resolve complex challenges, accelerate patient access, and integrate precision medicine approaches (coordinate key regulatory/clinical documents; proactive health authority engagement; robust risk mitigation).
- Collaborate with Precision Medicine, Research, Global/Regional Regulatory Leads, Global Regulatory Operations, and Quality; deliver timely guidance for health authority engagements and policy review.
- Oversee global precision medicine submissions and health authority interactions, including PSAs, SRD, Pre-subs, IDEs, and international related submissions for investigational use-only assays (with the Precision Medicine Lead).
- Provide regulatory support for product partnerships, vendor management, and business development.
- Shape policy via trade association engagement; maintain awareness of scientific/competitive/diagnostic industry trends.
- Engage stakeholders regularly to understand needs and risk areas and identify practical solutions.
Qualifications & Experience
- Degree: PhD, M.D., PharmD, or MS.
- >8–10 years of regulatory affairs and diagnostic-related development experience.
- Expertise in global diagnostic development; preferred proficiency in IHC, NGS, PCR, and/or mass spectrometry.
- Extensive experience with regulatory strategies for companion diagnostics/biomarkers; IVD and assay development including analytical validation, clinical development, manufacturing, and global regulatory submissions through commercialization.
- Proven leadership in complex health authority interactions and issue resolution.
- Regulatory standards: 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 cross-functional collaboration skills; ability to translate complex concepts into actionable insights.
- Facilitation/negotiation/strategic influence; ability to make timely, high-quality regulatory decisions balancing innovation and compliance.
- Inclusive leadership and continuous improvement mindset.
Travel
- Up to 20%.
Compensation & Benefits (as stated)
- Princeton, NJ: US $217,960–$264,113; San Diego, CA: US $240,460–$291,377.
- Health coverage; wellbeing support programs; financial well-being and protection (e.g., 401(k), disability, life insurance, etc.); Paid Time Off (includes flexible time off/paid vacation, holidays, and additional eligible time off including Global Shutdown).
- 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.
Key Responsibilities
- Drive development and execution of innovative, compliant global regulatory strategies for biomarkers and diagnostic tests across therapeutic areas.
- Design and operationalize a scalable regulatory framework supporting internal investigational assay development and clinical specimen testing; oversee external investigational use-only assay development to enable timely, compliant submissions.
- Serve as regulatory lead on the Translational Medicine CLIA Laboratory Steering Committee; provide strategic guidance and hands-on execution for investigational use assays for patient selection/stratification in BMS Phase I/II studies.
- Champion regulatory strategies to resolve complex challenges, accelerate patient access, and integrate precision medicine approaches (coordinate key regulatory/clinical documents; proactive health authority engagement; robust risk mitigation).
- Collaborate with Precision Medicine, Research, Global/Regional Regulatory Leads, Global Regulatory Operations, and Quality; deliver timely guidance for health authority engagements and policy review.
- Oversee global precision medicine submissions and health authority interactions, including PSAs, SRD, Pre-subs, IDEs, and international related submissions for investigational use-only assays (with the Precision Medicine Lead).
- Provide regulatory support for product partnerships, vendor management, and business development.
- Shape policy via trade association engagement; maintain awareness of scientific/competitive/diagnostic industry trends.
- Engage stakeholders regularly to understand needs and risk areas and identify practical solutions.
Qualifications & Experience
- Degree: PhD, M.D., PharmD, or MS.
- >8–10 years of regulatory affairs and diagnostic-related development experience.
- Expertise in global diagnostic development; preferred proficiency in IHC, NGS, PCR, and/or mass spectrometry.
- Extensive experience with regulatory strategies for companion diagnostics/biomarkers; IVD and assay development including analytical validation, clinical development, manufacturing, and global regulatory submissions through commercialization.
- Proven leadership in complex health authority interactions and issue resolution.
- Regulatory standards: 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 cross-functional collaboration skills; ability to translate complex concepts into actionable insights.
- Facilitation/negotiation/strategic influence; ability to make timely, high-quality regulatory decisions balancing innovation and compliance.
- Inclusive leadership and continuous improvement mindset.
Travel
- Up to 20%.
Compensation & Benefits (as stated)
- Princeton, NJ: US $217,960–$264,113; San Diego, CA: US $240,460–$291,377.
- Health coverage; wellbeing support programs; financial well-being and protection (e.g., 401(k), disability, life insurance, etc.); Paid Time Off (includes flexible time off/paid vacation, holidays, and additional eligible time off including Global Shutdown).