Director, Early Precision Medicine Regulatory Affairs
Bristol Myers Squibb
12 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.
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 for investigational assay development and clinical specimen testing; oversee external investigational use-only assay development to ensure alignment and timely, compliant submissions.
- Serve as regulatory lead on the Translational Medicine CLIA Laboratory Steering Committee; provide strategic and hands-on guidance for investigational use assays supporting patient selection/stratification in BMS Phase I/II studies.
- Champion regulatory strategies to resolve complex challenges, accelerate patient access, and integrate precision medicine approaches (coordination of regulatory/clinical documents, proactive health authority engagement, and risk mitigation).
- Lead inclusive, high-impact collaboration with Precision Medicine, Research teams, Global/Regional Regulatory Leads, Global Regulatory Operations, and Quality.
- Oversee global precision medicine submissions and health authority interactions (PSAs, SRD, Pre-subs, IDEs, and international submissions for investigational use-only assays), partnering with the Precision Medicine Lead.
- 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 trends.
- Engage stakeholders regularly to understand organizational needs and risks and identify practical solutions.
Qualifications & Experience / Required & Preferred Skills
- Solid scientific background (PhD, MD, PharmD, MS).
- 8–10+ years in regulatory affairs and diagnostic-related development.
- Deep expertise in global diagnostic development (US, EU, Canada, Australia, Japan, China, etc.); proficiency preferred in IHC, NGS, PCR, and/or mass spectrometry.
- Extensive biomarker and CDx regulatory strategy experience, including assay/IVD development (analytical validation, clinical development, manufacturing) through global submissions.
- Proven ability to lead teams through complex health authority interactions and issue resolution; develop/execute global regulatory strategies across drug and device development.
- Mastery of applicable standards/guidelines (e.g., GCP, GLP, CLIA, HIPAA, 21 CFR Parts 11/312/812/820, ISO 13485/14971, EU IVDR, CMDR, TGA, PMDA, NMPA, ICH).
- Ability to translate complex scientific/regulatory concepts for senior leadership and cross-functional teams; strong collaboration in matrix environments.
- Strong facilitation, negotiation, strategic influence, and accountability; ability to make timely, high-quality regulatory decisions.
- Inclusive leadership and continuous improvement mindset.
- Travel up to 20%.
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 for investigational assay development and clinical specimen testing; oversee external investigational use-only assay development to ensure alignment and timely, compliant submissions.
- Serve as regulatory lead on the Translational Medicine CLIA Laboratory Steering Committee; provide strategic and hands-on guidance for investigational use assays supporting patient selection/stratification in BMS Phase I/II studies.
- Champion regulatory strategies to resolve complex challenges, accelerate patient access, and integrate precision medicine approaches (coordination of regulatory/clinical documents, proactive health authority engagement, and risk mitigation).
- Lead inclusive, high-impact collaboration with Precision Medicine, Research teams, Global/Regional Regulatory Leads, Global Regulatory Operations, and Quality.
- Oversee global precision medicine submissions and health authority interactions (PSAs, SRD, Pre-subs, IDEs, and international submissions for investigational use-only assays), partnering with the Precision Medicine Lead.
- 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 trends.
- Engage stakeholders regularly to understand organizational needs and risks and identify practical solutions.
Qualifications & Experience / Required & Preferred Skills
- Solid scientific background (PhD, MD, PharmD, MS).
- 8–10+ years in regulatory affairs and diagnostic-related development.
- Deep expertise in global diagnostic development (US, EU, Canada, Australia, Japan, China, etc.); proficiency preferred in IHC, NGS, PCR, and/or mass spectrometry.
- Extensive biomarker and CDx regulatory strategy experience, including assay/IVD development (analytical validation, clinical development, manufacturing) through global submissions.
- Proven ability to lead teams through complex health authority interactions and issue resolution; develop/execute global regulatory strategies across drug and device development.
- Mastery of applicable standards/guidelines (e.g., GCP, GLP, CLIA, HIPAA, 21 CFR Parts 11/312/812/820, ISO 13485/14971, EU IVDR, CMDR, TGA, PMDA, NMPA, ICH).
- Ability to translate complex scientific/regulatory concepts for senior leadership and cross-functional teams; strong collaboration in matrix environments.
- Strong facilitation, negotiation, strategic influence, and accountability; ability to make timely, high-quality regulatory decisions.
- Inclusive leadership and continuous improvement mindset.
- Travel up to 20%.