Director, Early Precision Medicine Regulatory Affairs
Bristol Myers Squibb, San Diego, CA, United States
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 BMS Phase I/II studies—enabling business agility and advancing our commitment to precision medicine by ensuring the right drug reaches the right patient at the right time.
Champion innovative regulatory strategies to resolve complex challenges and accelerate patient access, while ensuring early integration of precision medicine approaches—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, including international related submissions for investigational use only assay 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 deep 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 on a regular basis to better understand organization needs and risk areas and identify pragmatic impactful solutions.
Qualifications & Experience
Degree Requirements: Solid scientific background, PhD, M.D., PharmD, MS.
Significant experience in regulatory affairs and diagnostic‑related development e.g., >8‑10 years.
Scientific & Diagnostic Expertise: Deep expertise in global diagnostic development—including, but not limited to key markets such as US, EU, Canada, Australia, Japan, China submissions, etc.—with preferred subject matter proficiency in IHC, NGS, PCR, and/or mass spectrometry, spanning assay design through regulatory approval.
Biomarker & CDx Strategy: Extensive experience in 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 complex health authority interactions and issue resolution, paired with deep expertise in developing and executing global regulatory strategies across drug and device development.
Regulatory Standards Mastery: Mastery 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 to ensure compliance and quality across investigational use only assay programs.
Communication & Collaboration: Skilled in translating complex scientific and regulatory concepts into clear, actionable insights for senior leadership and cross‑functional teams. Builds strong partnerships across internal and external stakeholders in matrixed environments to drive alignment and shared success.
Influence & Decision Making: Demonstrates high personal accountability and excels in facilitation, negotiation, and strategic influence. Proven ability to lead teams in making timely, high‑quality regulatory decisions that balance innovation, compliance, and enterprise impact.
Inclusive Leadership & Continuous Improvement: Values diverse perspectives, fosters a culture of continuous improvement, and encourages open dialogue on risks, issues, and successes.
Travel: Up to 20%
Compensation Overview Princeton - NJ - US: $217,960 - $264,113
San Diego - CA - US: $240,460 - $291,377
The starting compensation range(s) for this role are listed above for a full‑time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job‑related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.
Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit careers.bms.com/life-at-bms/.
Benefits
Health Coverage:
Medical, pharmacy, dental, and vision care.
Wellbeing Support:
Programs such as BMS Well‑Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
Financial Well‑being and Protection:
401(k) plan, short‑ and long‑term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
Work‑Life Benefits Include: Paid Time Off
US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)
Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non‑Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays
Based on eligibility* additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.
*Eligibility Disclosure: The summer hours program is for United States (U.S.) office‑based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote‑by‑design or lab‑based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program.
Candidate Rights BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information.
Equal Opportunity Employer Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.
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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 BMS Phase I/II studies—enabling business agility and advancing our commitment to precision medicine by ensuring the right drug reaches the right patient at the right time.
Champion innovative regulatory strategies to resolve complex challenges and accelerate patient access, while ensuring early integration of precision medicine approaches—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, including international related submissions for investigational use only assay 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 deep 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 on a regular basis to better understand organization needs and risk areas and identify pragmatic impactful solutions.
Qualifications & Experience
Degree Requirements: Solid scientific background, PhD, M.D., PharmD, MS.
Significant experience in regulatory affairs and diagnostic‑related development e.g., >8‑10 years.
Scientific & Diagnostic Expertise: Deep expertise in global diagnostic development—including, but not limited to key markets such as US, EU, Canada, Australia, Japan, China submissions, etc.—with preferred subject matter proficiency in IHC, NGS, PCR, and/or mass spectrometry, spanning assay design through regulatory approval.
Biomarker & CDx Strategy: Extensive experience in 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 complex health authority interactions and issue resolution, paired with deep expertise in developing and executing global regulatory strategies across drug and device development.
Regulatory Standards Mastery: Mastery 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 to ensure compliance and quality across investigational use only assay programs.
Communication & Collaboration: Skilled in translating complex scientific and regulatory concepts into clear, actionable insights for senior leadership and cross‑functional teams. Builds strong partnerships across internal and external stakeholders in matrixed environments to drive alignment and shared success.
Influence & Decision Making: Demonstrates high personal accountability and excels in facilitation, negotiation, and strategic influence. Proven ability to lead teams in making timely, high‑quality regulatory decisions that balance innovation, compliance, and enterprise impact.
Inclusive Leadership & Continuous Improvement: Values diverse perspectives, fosters a culture of continuous improvement, and encourages open dialogue on risks, issues, and successes.
Travel: Up to 20%
Compensation Overview Princeton - NJ - US: $217,960 - $264,113
San Diego - CA - US: $240,460 - $291,377
The starting compensation range(s) for this role are listed above for a full‑time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job‑related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.
Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit careers.bms.com/life-at-bms/.
Benefits
Health Coverage:
Medical, pharmacy, dental, and vision care.
Wellbeing Support:
Programs such as BMS Well‑Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
Financial Well‑being and Protection:
401(k) plan, short‑ and long‑term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
Work‑Life Benefits Include: Paid Time Off
US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)
Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non‑Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays
Based on eligibility* additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.
*Eligibility Disclosure: The summer hours program is for United States (U.S.) office‑based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote‑by‑design or lab‑based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program.
Candidate Rights BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information.
Equal Opportunity Employer Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.
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