Director, Early Precision Medicine Regulatory Affairs

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Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits services and programs that provide our employees with the resources to pursue their goals both at work and in their personal lives. Read more: 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 testsenhancing 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 developmentensuring 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 studiesenabling 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 approachesincluding 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 reviewensuring diverse expertise is integrated to drive precision medicine innovation.

• Oversee global precision medicine submissions and health authority interactionsincluding PSAs SRD Pre-subs IDEs including international related submissions for investigational use only assay in clinical studiesin 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 trendsacting 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

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 developmentincluding but not limited to key markets such as US EU Canada Australia Japan China submissions 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 developmentincluding 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 but not limited to GCP GLP CLIA HIPAA 21 CFR PartsISO 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%

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If you come across a role that intrigues you but doesnt perfectly line up with your resume we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

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 employees 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 offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include:

• 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.

All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.

*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.

Uniquely Interesting Work Life-changing Careers
With a single vision as inspiring as Transforming patients lives through science every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture promoting global participation in clinical trials while our shared values of passion innovation urgency accountability inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential site-by-design field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles onsite presence is considered an essential job function and is critical to collaboration innovation productivity and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

Supporting People with Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application or in any part of the recruitment process direct your inquiries to . Visit to access our complete Equal Employment Opportunity statement.

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: Protection

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