Director, Early Precision Medicine Regulatory Affairs

Director of Early Precision Medicine Regulatory Affairs

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

Experience Requirements: Significant experience in regulatory affairs and diagnostic-related development e.g., >8-10 years.

Key Competency Requirements

• Scientific & Diagnostic Expertise: Deep expertise in global diagnostic developmentincluding, 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 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 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%

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:

This role qualifies as a site-by-design role which 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.

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 adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Compensation Overview: Princeton - NJ - US: $217,960 - $264,113

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 https://careers.bms.com/life-at-bms/. Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.

Uniquely Interesting Work, Life-changing Careers

With a single vision as inspiring as "Transforming patients' lives through science ", every BMS