Description:
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
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: careers.bms.com/working-with-us
The Head, Precision Medicine & Digital Health, reports directly to the Vice President of Regulatory Innovation & Enterprise Delivery and has leadership responsibility for global regulatory strategy and execution for Precision Medicine and Digital Health products across the BMS portfolio.
Position Responsibilities
- Oversees a team of regulatory professionals to deliver compliant global regulatory strategies to support development of biomarkers, diagnostic tests, devices and digital health tools to enhance the value of our pharmaceutical products across therapeutic areas
- Provide innovative approaches to resolve complex regulatory issues and increase speed to patients
- Ensure global regulatory plans effectively accommodate appropriate precision medicine approaches by effectively integrating drug and diagnostic regulatory and submission plans including HA engagement plans and mitigation strategies
- Ensure high quality collaboration with Global Regulatory Leads and Regional Regulatory Leads by providing timely guidance and strategic partnership in health authority meetings and regulatory documentation spanning the drugs life-cycle
- Provides guidance on planning, writing and review of key dossier documents for submissions globally
- Represent BMS in key interactions with health authorities for precision medicine- and digital health-related topics
- Represent BMS on product partnership, vendor management and business development opportunities
- Manage complex cross-functional stakeholder alignment to ensure high quality collaboration with stakeholders including Translational Medicine to drive robust development of biomarker, companion diagnostic, devices and digital health tools
- Remains on the forefront of the relevant science and competitive landscape via actively contribution to policy shaping efforts including partnering with trade associations; viewed as an expert in its application to the regulatory process
- Ensures Global Regulatory Science representation as needed on internal governance committees
- Engages with customers on a regular basis to better understand organization needs and risk areas and identify pragmatic impactful solutions
- Accountable for coaching and career development to staff to maximize their potential
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.