Senior Director, U.S. Regional Clinical Operations

Company Background 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 commercialise 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 Director, U.S. Regional Clinical Operations as part of the Clinical team based in Somerset, NJ. Role Overview The Senior Director, U.S. Regional Clinical Operations is accountable for country-level clinical operational trial execution and delivery of the IND portfolio in the U.S. This position is responsible for providing strategic leadership and operational oversight for all U.S.-based clinical trial execution activities across the clinical development portfolio. This role serves as the leader of the U.S. Regional Clinical Operations organization, accountable for study startup, site activation, site management, monitoring oversight, enrollment performance, and inspection readiness activities executed within the United States. The position partners closely with Clinical Development, Clinical Trial Delivery, Regulatory Affairs, Data Management, Pharmacovigilance, Medical Affairs, Quality Assurance, and external service providers to ensure accelerated, high‑quality, and cost‑efficient trial execution. The Senior Director is responsible for building and leading a high‑performing field and in‑house clinical operations organization, optimising site engagement strategies, and delivering industry‑leading performance against startup and enrollment milestones. Serve as the clinical operations executive sponsor for the company’s U.S. Strategic Site Partnership Program, establishing long‑term collaborations with priority research institutions and site networks to improve startup cycle times, enrollment performance, protocol execution quality, and future portfolio readiness. This position serves as the senior regional operational leader representing U.S. site execution strategy within global clinical development teams and governance forums. Key Responsibilities Regional Clinical Operations Leadership Lead and develop the U.S. Regional Clinical Operations organization, including monitoring, site management, site activation, and regional startup personnel. Establish a scalable regional operating model capable of supporting a growing pipeline of complex studies, including oncology, hematology, cell therapy, and autoimmune disease programs. Define organisational goals, performance metrics, and operational standards for regional clinical operations. Foster a culture of accountability, patient centricity, operational excellence, innovation, and continuous improvement. Site Startup and Activation Leadership Provide strategic oversight of all U.S. study startup activities including site identification, feasibility, site selection, site activation, and enrollment readiness. Drive acceleration of startup timelines through optimisation of operational processes, vendor partnerships, and investigator engagement models. Partner with Regulatory Affairs, Legal, and Site Contracts teams to remove barriers to site activation. Establish performance metrics and cycle‑time targets for startup effectiveness across the portfolio. Site Management and Monitoring Oversight Provide leadership and oversight for regional site management and monitoring activities. Ensure monitoring strategies are effectively implemented and aligned with risk‑based quality management principles. Maintain oversight of site performance, protocol compliance, data quality, patient safety, and issue escalation activities. Ensure inspection readiness across all sites and clinical operations processes. Enrollment and Site Performance Optimisation Develop and execute strategies to improve patient recruitment, enrollment productivity, retention, and site engagement. Implement performance management frameworks to identify enrollment risks and deploy proactive mitigation plans. Utilise operational analytics to monitor site performance and optimise resource allocation. Establish strong relationships with investigators, site networks, key opinion leaders, and clinical research organisations. Site Relationship Management Develop and execute a comprehensive U.S. site engageme #J-18808-Ljbffr PVH (Tommy Hilfiger/Calvin Klein)