Associate Director, Precision Medicine Digital Health – Bristol Myers Squibb

Join to apply for the Associate Director, Precision Medicine Digital Health role at Bristol Myers Squibb. You will lead global regulatory strategies to support the development and approval of biomarkers, companion diagnostic tests, digital health solutions, and other devices associated with pharmaceutical products across therapeutic areas.

Position Summary

The Associate Director leads global regulatory strategies, assesses regulatory landscapes, manages regulatory risks, and develops global filing strategies. They co‑lead marketing application submission teams, ensure consistent responses to global Health Authority queries, and integrate regional regulatory strategies into global development plans. The role includes providing input into protocol development, responding to Clinical Trial Application (CTA) queries, and contributing to target labeling development. Requires strong background in regulatory affairs, team leadership, and project management within the medical device and pharmaceutical industries.

Duties / Responsibilities

• Leadership responsibility for global regulatory strategy to support the development of biomarkers, companion diagnostic tests, digital health, and other devices to enhance the value of our pharmaceutical products across therapeutic areas.
• Understand the regulatory landscape, assess regulatory risk, and develop global filing strategies.
• Co‑lead marketing application submission teams for indications at regulatory filing stage to develop content strategy for global dossiers.
• Ensure consistent positions are presented in responses to global Health Authority (HA) queries.
• Ensure global development plans meet global regulatory requirements by soliciting and integrating regional regulatory strategy input; develop global submission plans and HA interaction plans with the Global Regulatory sub‑team.
• Provide input into the development of protocol synopses and protocols; respond to Clinical Trial Application (CTA) queries on new protocols and amendments in compliance with HA deadlines.
• Contribute to the development of target labeling.
• Report to the Executive Director, Regulatory Affairs, Precision Medicine and Digital Health.

Qualifications

• Bachelor’s degree required; advanced scientific degree preferred (Masters, PhD, PharmD, BSN, etc.) with at least 7 years of US or EU Medical Device Regulatory Affairs experience.

Specific Knowledge, Skills, Abilities

• Experience successfully leading teams and representing regulatory functions on project teams within BMS and across alliance; leadership techniques to drive team development stages.
• Experience developing regulatory strategies in coordination with clinical plans and marketing objectives.
• Experience with clinical trial assays (CTA) in drug clinical trials, communicating between Diagnostic sponsor and Drug sponsor.
• Experience as a member of the Global Regulatory sub‑team, project working groups, or comparable industry experience.
• Competence in communicating regulatory strategy, issues, and risks in written and verbal format within teams, across functions, and to governing bodies.
• Ability to apply project management techniques and manage meetings effectively.
• Demonstrated ability to break down complex scientific content into logical components.
• Ability to coordinate global activities, facilitate issue resolution, and manage conflict.
• Demonstrated ability to drive quality decision‑making and prioritize tasks.
• Demonstrated ability to negotiate with and influence others.
• Understanding of the strategic and tactical role for the drug development process.
• Understanding of general global regulatory requirements for drugs in development.
• Understanding of R&D process and specific regulatory responsibilities/deliverables for the company decision points.

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.

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