Director, Early Precision Medicine Regulatory Affairs
Bristol Myers Squibb, Princeton, NJ, United States
Overview
Bristol Myers Squibb offers challenging, meaningful, life-changing work across all departments. This role presents opportunities to contribute to patient-focused discoveries and grow within a large, collaborative team. 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. 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. The position demands deep scientific and regulatory expertise (US, EU, Canada, PMD, TGA or Global Devices/IVD preferred), cross-functional leadership, and a commitment to innovation in early precision medicine. Key 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 Phase I/II studies—enabling business agility and advancing our commitment to precision medicine. Champion innovative regulatory strategies to resolve complex challenges and accelerate patient access, 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, and international submissions for investigational use only assays 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 awareness of scientific, competitive, and diagnostic industry trends—acting as a trusted resource for institutional knowledge and informing precision medicine decision-making across BMS. Engage with stakeholders regularly to understand organizational needs and risk areas and identify pragmatic, impactful solutions. Qualifications & Experience
Degree Requirements: Solid scientific background (PhD, MD, PharmD, MS). Significant experience in regulatory affairs and diagnostic-related development (8–10+ years). Scientific & Diagnostic Expertise: Deep expertise in global diagnostic development—including markets such as US, EU, Canada, Australia, Japan, and China—with proficiency in IHC, NGS, PCR, and/or mass spectrometry across assay design through regulatory approval. Biomarker & CDx Strategy: Extensive experience designing regulatory strategies for companion diagnostics and biomarkers, with deep expertise in assay and IVD development, including analytical validation, clinical development, manufacturing, and global regulatory submissions through commercialization. Regulatory Leadership & Strategic Planning: Proven ability to lead teams through health authority interactions and to develop and execute 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, and ICH guidelines for investigational use only programs. Communication & Collaboration: Ability to translate complex concepts into actionable insights for senior leadership and cross-functional teams; builds partnerships in matrixed environments. Influence & Decision Making: Strong accountability, facilitation, negotiation, and strategic influence in timely, high-quality regulatory decisions balancing innovation, compliance, and enterprise impact. Inclusive Leadership & Continuous Improvement: Values diverse perspectives and fosters a culture of continuous improvement and open risk discussion. Travel: Up to 20%. Notes
If you encounter a role that intrigues you but doesn’t perfectly align with your resume, you are encouraged to apply anyway. You could be one step away from work that will transform your life and career. Compensation & Benefits
Locations include Princeton, NJ and San Diego, CA with salary ranges listed below. Starting compensation and additional incentive cash and stock opportunities (based on eligibility) may be available. Final compensation is determined based on demonstrated experience. Eligibility for benefits varies by job and location; see the careers site for details. Princeton, NJ – US: $217,960 – $264,113 San Diego, CA – US: $240,460 – $291,377 Benefits include health coverage, wellbeing programs, and financial protection programs. Some benefits require enrollment and are subject to plan terms. Work-life and On-site Protocol
Uniquely interesting work, life-changing careers, and on-site expectations vary by role and location. Site-essential roles require 100% onsite shifts; site-by-design roles may allow hybrid work with at least 50% onsite; field-based roles require travel as an essential function. Disability Support & Rights
BMS provides accommodations for applicants with disabilities. For accommodations or accessibility information, contact adastaffingsupport@bms.com. See the Equal Employment Opportunity statement on Careers. Data Protection
We protect applicant data in accordance with data privacy policies. We will never request payments or sensitive information during recruitment. For concerns, contact TAEnablement@bms.com. Job posting status: Active. Position: Director, Early Precision Medicine Regulatory Affairs (R1601369).
#J-18808-Ljbffr
Bristol Myers Squibb offers challenging, meaningful, life-changing work across all departments. This role presents opportunities to contribute to patient-focused discoveries and grow within a large, collaborative team. 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. 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. The position demands deep scientific and regulatory expertise (US, EU, Canada, PMD, TGA or Global Devices/IVD preferred), cross-functional leadership, and a commitment to innovation in early precision medicine. Key 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 Phase I/II studies—enabling business agility and advancing our commitment to precision medicine. Champion innovative regulatory strategies to resolve complex challenges and accelerate patient access, 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, and international submissions for investigational use only assays 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 awareness of scientific, competitive, and diagnostic industry trends—acting as a trusted resource for institutional knowledge and informing precision medicine decision-making across BMS. Engage with stakeholders regularly to understand organizational needs and risk areas and identify pragmatic, impactful solutions. Qualifications & Experience
Degree Requirements: Solid scientific background (PhD, MD, PharmD, MS). Significant experience in regulatory affairs and diagnostic-related development (8–10+ years). Scientific & Diagnostic Expertise: Deep expertise in global diagnostic development—including markets such as US, EU, Canada, Australia, Japan, and China—with proficiency in IHC, NGS, PCR, and/or mass spectrometry across assay design through regulatory approval. Biomarker & CDx Strategy: Extensive experience designing regulatory strategies for companion diagnostics and biomarkers, with deep expertise in assay and IVD development, including analytical validation, clinical development, manufacturing, and global regulatory submissions through commercialization. Regulatory Leadership & Strategic Planning: Proven ability to lead teams through health authority interactions and to develop and execute 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, and ICH guidelines for investigational use only programs. Communication & Collaboration: Ability to translate complex concepts into actionable insights for senior leadership and cross-functional teams; builds partnerships in matrixed environments. Influence & Decision Making: Strong accountability, facilitation, negotiation, and strategic influence in timely, high-quality regulatory decisions balancing innovation, compliance, and enterprise impact. Inclusive Leadership & Continuous Improvement: Values diverse perspectives and fosters a culture of continuous improvement and open risk discussion. Travel: Up to 20%. Notes
If you encounter a role that intrigues you but doesn’t perfectly align with your resume, you are encouraged to apply anyway. You could be one step away from work that will transform your life and career. Compensation & Benefits
Locations include Princeton, NJ and San Diego, CA with salary ranges listed below. Starting compensation and additional incentive cash and stock opportunities (based on eligibility) may be available. Final compensation is determined based on demonstrated experience. Eligibility for benefits varies by job and location; see the careers site for details. Princeton, NJ – US: $217,960 – $264,113 San Diego, CA – US: $240,460 – $291,377 Benefits include health coverage, wellbeing programs, and financial protection programs. Some benefits require enrollment and are subject to plan terms. Work-life and On-site Protocol
Uniquely interesting work, life-changing careers, and on-site expectations vary by role and location. Site-essential roles require 100% onsite shifts; site-by-design roles may allow hybrid work with at least 50% onsite; field-based roles require travel as an essential function. Disability Support & Rights
BMS provides accommodations for applicants with disabilities. For accommodations or accessibility information, contact adastaffingsupport@bms.com. See the Equal Employment Opportunity statement on Careers. Data Protection
We protect applicant data in accordance with data privacy policies. We will never request payments or sensitive information during recruitment. For concerns, contact TAEnablement@bms.com. Job posting status: Active. Position: Director, Early Precision Medicine Regulatory Affairs (R1601369).
#J-18808-Ljbffr