Senior Manager, Medical Operations and Product Sciences

Quick Facts

• Role: Senior Manager, Medical Operations and Product Sciences (ex-US Medical Affairs)
• Focus: PAN-CAR T therapeutic area expertise and CAR-T product support across approved products and pipeline assets
• Key areas: global strategy execution, medical data generation, NCP/OOS & special scenario management, launch readiness and site onboarding, and digital/process innovation

Description

The Senior Manager serves as a therapeutic area expert for pan-CAR T and provides clinical/scientific support for CAR-T products and compounds in various clinical stages. Reporting to the Director of Medical Operations and Product Sciences, the role supports worldwide (WW) Medical Affairs functions by contributing to global strategy and supporting launch implementation for new indications in key countries. The position contributes therapeutic area knowledge to content and presentations, assists with site onboarding/training, and travels as needed to support designated CAR-T sites.

Responsibilities

• Execute and align global pan-CAR T Medical Affairs strategy and tactics across current and pipeline assets (Breyanzi, Abecma, arlo-cel, zola-cel), supporting global affiliates for cell therapy launches
• Support design and planning of medical data generation (Medical Affairs-sponsored studies, ISR, registries, evidence-generation initiatives)
• Draft and review medical/educational materials for approvals (strategy plans, abstracts, posters, manuscripts, slides, MI letters, educational content, Commercial Brand plan input)
• Manage non-conforming product (NCP), OOS, off-label requests, re-treatment, and infectious-disease clinical scenarios in partnership with the (Associate) Medical Director
• Co-author Integrated Health Hazard Assessments (IHHAs) and support benefit/risk conclusions for release decisions
• Coach Affiliate Medical Teams for autonomous NCP/OOS handling while maintaining quality oversight and consistent decision-making
• Partner with Tech Ops, business process owners, and Quality on manufacturing failure trend monitoring, root-cause analyses (RCAs), and mitigation strategies
• 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
• Support patient-access expansion initiatives (e.g., outpatient administration, early discharge), including advisory boards, operational toolkits, consensus publications, and rollout with AMTs
• Support IT teams in shaping, piloting, and rolling out global digital solutions for NCP management, site communication, and manufacturing analytics
• Maintain external engagement with KOLs and represent WW Medical Affairs at advisory boards, steering committees, congresses, and symposia
• Provide regulatory input through cross-functional forums (e.g., MRB, SMT, Franchise Team, WW Commercial/Clinical/Quality/Manufacturing, Market Access, launch teams)
• Contribute to Health Authority responses with medical operations/product sciences expertise as applicable

Benefits

• Health coverage: medical, pharmacy, dental, and vision care
• Wellbeing support: employee assistance and wellbeing programs
• Financial wellbeing and protection: 401(k), disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support
• Paid time off and flexible time off options (eligibility-based)
• Leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs; annual Global Shutdown between Christmas and New Year’s Day (eligibility-based)