Bristol Myers Squibb Group Medical Director Medical Safety Assessment, Immuno-Oncology, Global Pharma & Epidem in Hopewell, 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.
The Group Medical Director is responsible for the strategic oversight and delivery of medical safety assessment for assigned, new assets in the Immuno-Oncology (I/O) TA, through effective management of a team of medical safety assessment physicians (MSAPs). The GMD/TA Lead reports into the Vice President (VP), MSA, Oncology & Immuno-Oncology, GPV&E. In addition to managing MSAPs, the TA Lead will have asset level responsibility.
The GMD manages a team of 3 to 5 medical safety assessment physicians (MSAPs) who function as Medical Surveillance Team (MST) Chairs with oversight responsibility for safety of assigned project(s). GMD/TA lead will train, coach, mentor, and reward MSAPs, toward the goal of maintaining a highly performing team in line with the BMS GPVE vision and the BMS people strategy. The GMD manages product assignments in concert with the VP, MSA, I/O products.
The GMD provides a senior perspective for the activities of the MSAPs, and assures that work projects are completed to time and quality standards. Activities in scope for the oversight of the MSA TA Lead include:
· Signal detection, signal assessment, and any resultant activities such as revisions to core safety information
· Risk management activities, including risk strategies for assets in all phases of development and life-cycle
· Internal and external handling/communication of safety issues, including MST meetings
· Review and direction for the strategic decisions guiding the content of aggregate and ad hoc safety reports
The role will include an individual contributor component involving direct oversight of one or more assets in the relevant area(s). This component includes, but is not limited to: safety oversight, signal detection and assessment activities, risk management and MST Chair responsibilities.
The position holder will partner closely with other GPVE TA Leads/TA Heads and other functions within GPV&E such as PV Science, Epidemiology, and the EU-Qualified Person for Pharmacovigilance (QPPV), Medical Safety Review, and International PV. Frequent interactions will also occur with GPV&E leads in operational areas: Safety Reporting, Quality/Compliance, Project Management, and Resource Planning. The role will also partner with therapeutic area Leads/Heads in other R&D functions, such as research departments encompassing discovery, early and late development, medical affairs, health economics, regulatory affairs and biostatistics.
In conducting the duties of the role, the position holder will interface with senior management committees, such as the Medical Review Group (MRG), First-in-Human Subcommittee of MRG (MRG-HES), GPV&E Senior Leadership Team (SLT), and GRSB SLT, as well as with Development and Commercialization Teams.
The position holder will serve as a standing member of the GPV&E Safety Science Forum (SSF) and the Extended GPV&E SLT. The GMD will contribute to and/or lead process improvement projects as requested by the VP, MSA, Oncology & I/O and/or the Head of GPV&E.
The successful candidate will have a record of success in the growth and development of his/her medical reporting staff along with accomplishments in strategic and analytic work output. The candidate will demonstrate the drive to deliver speed and rigor in decision making, collaboration, innovation, continuous improvement and growth to achieve the BMS vision.
• Medical doctorate degree required
• 5 or more years of pharmaceutical experience.
• Strong understanding of pharmacovigilance regulations and experience in pharmacovigilance.
• Demonstrated ability in leading high-performing teams in a matrix and collaborative environment.
• Deep clinical knowledge, with medical practice experience.
• Excellent ability to communicate, specifically on medical and scientific topics.
• Demonstrated skills in scientific analysis and reasoning.
• Solid understanding of clinical development and/or epidemiology is also highly desirable.
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.