Senior Manager, Medical Operations and Product Sciences
Bristol-Myers Squibb (BMS) · Princeton - NJ - US
Job description
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. Position Summary At BMS, we are committed to the advancement in science with the drive to improve every day for the benefit of patients. To accelerate our position as leaders in cell therapy and serve patients around the world, we are committed to being at the forefront of change. Reporting to the Director of Medical Operations and Product Sciences, the Senior Manager will represent ex-US Medical Affairs as a therapeutic area expert (PAN-CAR T) and provide clinical/scientific support for approved CAR T products as well as CAR T compounds in various stages of clinical development. A major focus will be on interacting and aligning with global functions and supporting Medical Affairs functions in worldwide (WW) affiliates. This will be achieved through active participation in WW cross-functional teams, where the individual will contribute to the global strategy and support the launch implementation for new indications in key countries from a Medical Affairs perspective. The position will contribute therapeutic area knowledge to content creation, strategic and tactical discussions, and presentations with internal colleagues, as well as external experts and investigators. They will assist with site onboarding activities, including training, and must be capable of traveling to provide on-site support for designated CAR T sites as needed, in collaboration with the medical field team. They will represent Worldwide Medical as required, contributing therapeutic area knowledge in Cell Therapy products. He/she will support the escalation process for the affiliate medical teams (AMTs) for handling nonconforming CAR T products and contribute to communication plans for site level strategy. This individual’s responsibilities will include supporting the strategic and tactical planning of medical affairs CAR T program site support and acting in a support capacity for the internal site launch experience. Key Responsibilities Ex-US pan-CAR T strategy & tactic execution — Support the execution of the global pan-CAR T strategy and tactics in alignment with the global disease strategy, supporting the delivery of the pan-CAR T Medical Affairs plan across current and pipeline assets (Breyanzi, Abecma, arlo-cel, zola-cel) and supporting global affiliates for Cell Therapy launches. Contribute to global and regional pan-CAR T strategy priorities and the WW Cell Therapy Franchise (CTF) strategy in close collaboration with WW Commercial, WW Clinical, WW Quality, WW Manufacturing and Market Access colleagues. Support the design and planning of medical data generation — including Medical Affairs–sponsored studies, Investigator-Sponsored Research (ISR), registries and other evidence-generation initiatives. Draft and review medical and educational materials for approval (strategy plans, abstracts, posters, manuscripts, slides, MI letters, educational content and Commercial Brand plan input). NCP, OOS & special treatment scenario management — Serve, alongside the (Associate) Medical Director, as the point of contact for Affiliate Medical Teams (AMTs) and sites of care on non-conforming product (NCP), out-of-specification (OOS), off-label requests, re-treatment and infectious-disease clinical scenarios. Co-author Integrated Health Hazard Assessments (IHHAs), including benefit/risk conclusions supporting release decisions. Support and coach AMTs toward autonomous NCP/OOS case handling as part of the decentralized NCP/OOS management model, while maintaining close alignment, quality oversight and consistency of medical decision-making across regions. Manufacturing success, TAT & failure-mode partnership — Support the ex-US medical partnership with Tech Ops, Business Process Owners (BPOs) and Quality on manufacturing failure trend monitoring, root-cause analyses (RCAs) and mitigation strategies. Ex-US launch readiness & site onboarding — Co-lead ex-US medical readiness and site onboarding for CAR-T launches (including arlo-cel and pipeline assets). Draft and review product-handling guides, SOPs, training materials and site-facing educational content. Ex-US CART Class & Patient-access Expansion: Support ex-US strategic initiatives to expand patient access and optimize CAR-T treatment pathways (e.g., outpatient administration, early discharge), including advisory boards, operational toolkits, consensus publications and tactical rollout with AMTs. Digital & process innovation — Support IT teams in shaping, piloting and rolling out global digital solutions supporting NCP management, site communication and manufacturing analytics. External engagement, KOL & TL management — Cultivate and maintain strong relationships with external partners, including KOLs. Represent WW Medical Affairs at advisory boards, steering committees, congresses and local symposia. Cross-functional representation & regulatory input — Support Global Medical Affairs representation on key cross-functional forums and teams, acting as delegate where appropriate (e.g., Material Review Board (MRB), Safety Management Team (SMT), Franchise Team, WW Commercial, WW Clinical, WW Quality, WW Manufacturing, Market Access, launch teams). Contribute to sponsor responses to Health Authority requests with medical operations and/or product sciences subject matter expertise, where applicable. Qualifications & Experience MD, PharmD, PhD or equivalent advanced scientific/clinical degree. Direct clinical experience in patient care (hematology/oncology, cell therapy or a related field) is a plus. At least 2-3 years academic/industry experience strongly preferred, including expertise in cellular therapy and/or hematological malignancies is a strong plus. Excellent analytical skills and solid experience in translating medical/clinical information into medical affairs strategies. Proficiency in critical data review and interpretation. Excellent oral and written communication skills, including presentations to large groups, Sr leadership, facilitation of interactive discussions, and 1:1 discussions with thought leaders and hospital organizations. Strategic Thinking: Ability to understand overarching company goals, contribute to strategic assessments, and help frame clear choices and recommendations. Experience contributing to complex interactions that drive business strategy & priorities engaging both internal and external stakeholders. Cross-Functional Experience: Experience working across a range of medical and/or clinical development roles is a plus. Highly collaborative, possess a record of building and maintaining cross-functional relationships, and able to communicate business topics effectively with senior leadership, peers, and others. Analytical Skills: Experience in analytics, particularly in relation to product launches. Able to innovate, analyze and solve problems with diligence. Project Management: Experience in project management with the ability to develop clear action plans and execute them. Interpersonal Skills: Ability to build relationships, influence, and drive organizational engagement at all level
Verified and listed by ActiveJobs. Applications are made directly on Bristol-Myers Squibb (BMS)'s own career page — we never sit in the middle.