Bristol Myers Squibb Associate Director Regulatory Strategy Oncology (D7, GRTL - Precision Medicine) in Princeton, New Jersey
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. 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.
Global Regulatory Strategy Lead (GRTL) for Precision Medicine will have leadership responsibility for developing and 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, commercial 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.
Ensure consistent positions are presented in responses to global health authority (HA) queries.
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, PMAs and labeling for drug and diagnostic products.
Solid scientific background, Ph.D., M.D., PharmD, MS, or BS with significant experience in regulatory affairs or diagnostic related development (e.g. > 4 years) .
Understanding of scientific content and complexities and good knowledge of Oncology drug development is desired.
Experience working with external partners.
Good interpersonal skills; willingness to leverage strengths of the team and cooperate with peers in a cross-functional environment.
Experience in successfully leading teams; Demonstrated ability to drive quality decision-making. Demonstrated ability to organize / prioritize tasks.
Demonstrated ability to negotiate with and influence others. Demonstrated ability to facilitate issue resolution and conflict management. Direct experience in developing strategy and leading teams through interactions with health authorities.
Track records of issue resolutions with main regulatory authorities; demonstrated ability to break down complex, scientific content into logical components.
Ability to broadly represent department functions on project team in a matrix organization. Demonstrated ability to coordinate global activities.
Experience utilizing leadership techniques to drive a team through the stages of team development.
Prior experience with SRDs, IDEs, and PMAs and experience developing companion diagnostics is highly desired.
Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.