Senior Manager, Evidence Generation Operations

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 RD 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 a Senior Manager, Evidence Generation Operations as part of the Medical Affairs team based Remotely . Role Overview The Senior Manager, Medical Affairs, Evidence Generation Operations will be a key contributor focused on execution of evidence generation activities within Legend Biotech’s US Medical Affairs organization. In this role, you will ensure that clinical research and evidence generation activities – including observational RWE studies, Investigator-Initiated Studies (IIS), and collaborative studies – are executed efficiently, on time, and in full compliance with all applicable regulations and company policies. This position plays a critical role in advancing Legend’s cutting-edge cell therapy for multiple myeloma and our growing oncology pipeline. By delivering high-quality real-world data and insights, you will inform medical strategy and help improve patient outcomes. As Senior Manager, Evidence Generation Operations, you will work under the strategic guidance of the Associate Scientific Director, RWE Generation, focusing on hands-on trial execution. You will collaborate cross-functionally with colleagues in Medical Affairs, Clinical Operations, Regulatory, Data Management, Biostatistics, Pharmacovigilance, Compliance, and external partners to drive seamless study implementation and results dissemination. The ideal candidate brings a growth mindset—both professionally and organizationally—and is comfortable adapting to shifting priorities while maintaining high-quality execution. Key Responsibilities Evidence Generation Project Management: Provide operational management and coordination for a broad range of Medical Affairs–led evidence generation projects (including real-world evidence studies, investigator-initiated studies, and other observational research). Ensure these projects are executed in alignment with Medical Affairs objectives, delivered on time, and fully compliant with regulations and company policies. Site Vendor Management: Oversee CROs, academic collaborators, and vendors to ensure quality deliverables and timeline adherence. Anticipate and address risks, remove operational barriers, and keep studies on track. Budget Resource Management: Manage budgets and resources for evidence generation activities, tracking spend and forecasting needs to support timely decisions. Partner with Finance and Procurement to enable contracting, payments, and policy-compliant execution. Cross-Functional Coordination: Serve as a central coordinator across internal teams and external partners, ensuring clear communication, timely issue resolution, and alignment on study plans (Clinical Development, Regulatory, Drug Safety/Pharmacovigilance, Legal, Compliance, and co-development partners). Regulatory Compliance: Ensure all evidence generation activities comply with relevant regulatory guidelines (e.g., FDA, EMA) and internal standards. Always keep studies audit-ready by maintaining thorough documentation. Data Quality and Reporting: Ensure high ... (truncated, view full listing at source)