Hybrid Director, Early Precision Medicine Regulatory Affairs

at Bristol Myers Squibb

• Job title: Director, Early Precision Medicine Regulatory Affairs
• Job type: Full Time
• Experience level: Lead
• Salary: $217,960 - $295,806 per year
• Degree requirement: Postgraduate Degree
• Tech skills: Google Cloud Platform
• Location requirements: Hybrid, Princeton, United States

About the role

• Director leading global regulatory strategy for biomarkers and diagnostics at Bristol Myers Squibb. Focusing on early-stage development and supporting registrations across various markets.

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.
• Engages with stakeholders on a regular basis to better understand organization needs and risk areas and identify pragmatic impactful solutions.

Requirements

• Solid scientific background, PhD., M.D., PharmD, MS
• Significant experience in regulatory affairs and diagnostic-related development e.g., >8-10 years.
• 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.
• 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.
• 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, but not limited to 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 .
• 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.
• 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.
• Values diverse perspectives, fosters a culture of continuous improvement, and encourages open dialogue on risks, issues, and successes.

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.