Senior Director, U.S. Regional Clinical Operations

Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life-threatening diseases. Headquartered in Bridgewater, New Jersey, we are advancing the next generation of cell therapy through a portfolio of innovative technologies, including autologous, allogeneic, and in vivo cell therapy approaches. Our research spans chimeric antigen receptor T-cell (CAR-T), T-cell receptor (TCR-T), natural killer (NK) cell-based therapies, and other emerging platforms designed to transform the treatment of serious diseases. From our global network of research and development sites, we are committed to discovering and developing safe, effective, and cutting-edge therapies for patients worldwide.

Legend Biotech entered into a global collaboration agreement with Johnson & Johnson to jointly develop and commercialize CARVYKTI® (ciltacabtagene autoleucel; cilta-cel). Through this strategic partnership, we combine complementary expertise and capabilities to advance innovative immunotherapies for patients living with 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, optimizing 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

• 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 organizational goals, performance metrics, and operational standards for regional clinical operations.
• Foster a culture of accountability, patient centricity, operational excellence, innovation, and continuous improvement.
• 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 optimization 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.
• 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. <li style="font-family: