Associate Director, Global Regulatory Strategy - Oncology

Bristol-Myers Squibb Princeton, NJ

About the Job

Description:

About Bristol-Myers Squibb\:


Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.


One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. And driven to make a difference, from innovative research to hands-on community support. 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 the resources to pursue their goals, both at work and in their personal lives.



Associate Director, Global Regulatory Strategy - Oncology


Responsibilities\:

  • Global Regulatory Strategy Lead (GRTL) will have leadership responsibility for implementing the global regulatory strategy to support the development and delivery of diagnostic tests to enhance the value of our pharmaceutical products across therapeutic areas.
  • Provide regulatory support and guidance to Diagnostic Partners, Global Regulatory Leads (GRTLs), development teams and/or project drug/diagnostic subteams on the regulatory strategy and execution of the integrated drug / diagnostic development plan.
  • Ensure global regulatory plans support a precision medicine approach (ie integrated drug/diagnostic regulatory and submission plans), including HA engagement plans and mitigation strategies.
  • Support the preparation of health authority documents and governance presentations containing precision medicine plans.
  • Propose innovative approaches to resolve complex regulatory issues and increase speed to patients.
  • Provide strategic input on key development documents, clinical protocols, study reports, IBs, INDs, CTAs, IDEs, SRDs and PMAs.

Qualification:

  • Advanced technical degree, e.g., PhD, MD, PharmD, M.S. is preferred
  • 8 years of related experience
  • Experience in successfully leading teams
  • Experience working with external partners
  • Demonstrated matrix leadership skills and the ability to work effectively across multiple disciplines internal and external to the organization.
  • Strong understanding of the drug development process and global regulatory requirements for drugs in development
  • Understanding of science in oncology and impact on the regulatory process
  • Prior experience with SRDs, IDEs, and PMAs and experience developing companion diagnostics is highly desired