Executive Director, Medical Safety Assessment Therapeutic Lead, Neuroscience

Working with Us 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. 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. Functional Area Description The Worldwide Patient Safety (WWPS) group is responsible for ensuring the safety of our medicines. WWPS pharmacovigilance and pharmacoepidemiology deliverables include single case and aggregate safety monitoring, safety reporting, contributing to benefit-risk assessment, risk management planning and strategy, execution of certain postmarketing commitments, and ensuring compliance with global regulatory requirements. Position Summary * Provide strategic oversight & delivery of medical safety assessment for assets in therapeutic area (TA) by effective management of safety physician team. * Oversee safety activities and benefit-risk strategies for assigned compound(s)/ program(s) and chair the product/TA Safety Management Team (SMT). * Oversee, Review, and Approve aggregate safety review documents as well as safety sections of relevant clinical trial documents and regulatory filings. * Oversee team in evaluation & management of signals emerging from any data source. Guide strategy for signal evaluation (eg, case-series, literature review, HA/ claims database). Ensure documentation by Safety Topic Review/Signal Report or other means of communication. * Approve safety labeling activities for assigned products. Provide Safety Subject Matter Expertise for input to regulatory product labeling. * Drive change in the organization and adoption of new processes. Assist the MSA TA Head in developing and maintaining state-of-the-art PV processes and procedures within BMS R&D and WWPS. Position Responsibilities General Product Support * Oversee safety activities and benefit-risk strategies for assigned compound(s)/ program(s) and chair the product/TA Safety Management Team (SMT). * Oversee, Review, and Approve aggregate safety review documents (eg, Development Safety Update Reports [DSUR], Periodic Benefit-Risk Evaluation Reports [PBRER]) and safety sections of relevant clinical trial documents (eg, protocols, clinical study reports [CSR], investigator brochures [IB], informed consent forms [ICF]) and regulatory filings (eg, clinical trial applications [CTA], marketing authorization applications [MAA]). * Oversee team in evaluation & management of signals emerging from any data source. Guide strategy for signal evaluation (eg, case-series, literature review, HA/ claims database). Ensure documentation by Safety Topic Review/Signal Report or other means of communication. * Approve safety labeling activities for assigned products. * Provide Safety Subject Matter Expertise for input to regulatory product labeling. * Support the EU QPPV or other regional or local Qualified Person for PV relative to issues relating to assigned products. * Provide input to R&D publication strategy/ plan & ensure safety input to publications/ presentations. Clinical Development * Oversee the global safety strategy for assigned compounds in development. Support global submission document production. Review final summary documents. * Oversee medical safety development and execution of benefit-risk...