Associate Scientific Director, Medical Affairs Real World Evidence (RWE) Generation
Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide.
Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel). Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma.
Legend Biotech is seeking Associate Scientific Director, Medical Affairs Real World Evidence (RWE) Generation as part of the Medical Affairs team based remotely.
Role Overview
The Associate Scientific Director, US Medical Affairs, will supervise the Real World Evidence (RWE) strategy and evidence generation initiatives at Legend Biotech. This role is responsible for the design, execution, and dissemination of RWE studies and related research activities to support medical adoption, product differentiation, and lifecycle management. The position requires a strategic and hands-on leader with deep expertise in clinical research methodologies, study design, and cross-functional collaboration.
This position reports directly to the Medical Scientific Director. The Associate Scientific Director will work closely with colleagues across Medical Affairs, Clinical Development, Regulatory Affairs, Commercial, as well as external and alliance partners.
Key Responsibilities
- Lead the development and execution of RWE generation to address evidence needs in line with Legend Medical Affairs objectives. Formulate research questions, develop study protocols, and design robust methodologies to generate impactful real-world data. A strong collaborative approach with Alliance partners is required.
- Oversee all data generation activities, including MA led Phase IV studies, RWE studies, Investigator Initiated Studies (IIS), and collaborative research. Manage projects from strategy through execution and dissemination.
- Conduct annual data gap analyses to identify high-value medical affairs-driven studies. Provide leadership in lifecycle evidence management and ensure timely initiation and completion of prioritized studies.
- Manage project budgets, ensuring efficient resource allocation, vendor management, and timely delivery within established financial parameters.
- Collaborate with internal teams (Clinical Development, Regulatory, Commercial) and external partners to maximize evidence generation and address emerging data needs.
- Oversee all aspects of study management, including enrollment, milestone tracking, and reporting progress to stakeholders.
- Represent Legend at relevant internal and external meetings, as well as congresses, workshops, investigator meetings, and other scientific engagements.
- The Associate Scientific Director will typically have the authority to make decisions related to direction, methodologies, approaches in the evidence generation processes. You can also make decisions related to project execution, including timelines, milestones, and resource allocation within budget. Higher-level approvals are required for those related to significant budget allocations, strategic shifts, or major collaborations that have substantial financial or long-term implications.
Requirements
Advanced terminal degree (MD, PharmD, PhD) or other advanced medical degree (NP, PA, etc.) preferred.Minimum 5 years of experience in medical affairs and / or clinical research required, with preference for a track record in RWE strategy and evidence generation.Understanding of research methodologies, protocol development, data analysis, and interpretation of real-world data. Familiarity with regulatory and compliance requirements in RWE research.Demonstrated success in managing complex projects and budgets, and working in cross-functional teams in a matrix environment with a results focused attitude.Excellent written and verbal communication skills, with the ability to translate complex scientific concepts into actionable insights for diverse audiences.Demonstrated proficiency with the most current computer operating systems, Microsoft Office 2013, SharePoint, Adobe Acrobat Professional, Concur, Veeva, and other PC-based applications. Familiar with AI based platforms including Copilot.