Bristol Myers Squibb Company

Team Leader - Senior Director, Global Regulatory Strategy, Oncology

Location
Princeton, NJ, United States
Posted
Sep 16, 2020
Ref
R1529584
Required Education
Doctorate/PHD/MD
Position Type
Full time
At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science.In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Team Leadership responsibility for Oncology products in development and through life cycle management taking into account all relevant guidance, commercial needs and company objectives.

Description
  • Leadership responsibility for global regulatory strategy across multiple DTs, including the New Assets and/or Full Development Teams across indications. This requires coaching and mentoring of Global Regulatory Leads (GRL) responsible for the leadership of their respective DTs and US lead (USL) responsible for their assigned US submissions.
  • Provides guidance to the regional strategists and collaborates in strategic meetings with health authorities.
  • Represents BMS in key interactions with Health Authorities.
  • Provides ongoing feedback, coaching, and career development support to staff in order to maximize their potential.
  • Remains on the forefront of the relevant science and competitive landscape including detailed competitive intelligence and is viewed as an expert in its application to the regulatory process.
  • Provides guidance on planning, writing, review of key dossier documents for submission globally; signs off on integrated summary documents
  • Ensure Global Regulatory Sciences representation as needed in governance or strategic teams or committees.


Qualifications

• Ph.D., M.D., PharmD. , MS or commensurate with experience.
  • Understanding of policy, laws, regulations and guidelines as they apply to U.S. FDA for drug development and approval.
  • Understanding of drug development process and understanding of scientific content and complexities related to a project in Oncology.
  • Direct experience in developing strategy and leading teams through interactions with FDA or other Health Authorities.
  • Experience in initiating and conducting successful interactions within FDA or other Health Authorities.
  • Ability to work successfully in a matrix environment and to lead teams successfully toward drug approvals.


Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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.