Director of Clinical 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 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 Director of Clinical Operations as part of the Clinical Operations team based in Somerset, NJ. 

Role Overview

The Director, Clinical Operations is responsible for leading the planning and management and oversight of the Legend Biotech pipeline studies. The Director, Clinical Operations will be responsible for all aspects of study conduct and CRO oversight and a point of contact for clinical study project management, communications and daily operations for the clinical INDs being held by Legend Biotech USA, Inc. Experience and knowledge of end to end management of clinical trial conduct, knowledge of the pharmaceutical industry and an understanding of clinical drug development, clinical trials operations and FDA/ICH regulatory requirements is essential.
The position involves working closely with the Sr. Director of Clinical Research Operations and Data Analytics Strategy and collaboration with cross-functional teams, including safety, study monitoring and coordinators, data management, biostatistics, bio analytics, manufacture, supply chain, regulatory, project management, medical affairs, and quality. This position requires collaboration with project management to support the creation of study project plans, and end-to end-study timelines for execution of clinical trials from IND submission activities to first site activation. In addition, the position will ensure program consistency across studies, drive research and operational excellence through process improvement, and represent the clinical trial operation function at internal and external meetings.
Experience and knowledge of end-to-end management of clinical trial conduct, knowledge of the pharmaceutical industry and an understanding of clinical drug development, cellular/gene industry landscape, clinical trials operations and FDA/ICH regulatory requirements is essential. The ability to manage, mentor, oversee develop new clinical operation team members which include and not limited to: Sr. CTMs, CTMs, and CTAs.

Key Responsibilities  

• Direct end-to-end clinical trial management activities domestically and globally: i.e. lead and take ownership in all aspects of study planning, start-up and oversight of study execution within clinical operations.
• Lead clinical operation execution of complex protocols within a matrix environment (Project Management, Safety, outsourcing and vendor alliance management Data Management, Statistics, Clinical Supplies, Safety, etc.).
• Define project timelines & deliverables, working closely with the Sr. Director of Clinical Operations, Project Management, and cross-functional team and assure that they are consistent with company strategy and drive clinical operations performance
  
• Collaborate with PM to create study project plans, end-to end-study timelines for execution of clinical trials from IND submission activities to first site activation
  
• Collaborate with tech ops, procurement, legal, project management, finance, and other cross-functional team members to lead monthly process improvement meetings for optimal clinical operation performance.
  
• Helps with developing new work streams, SOPs, study template, tracking tools, dashboards to support optimal clinical operation performance
  
• Report on all aspects of the study progress at a granular level to operations management. Effective, consistent & regular tracking of project (s). Prepare and present project reports as required. Plans, executes, and leads study-specific meetings as needed (e.g., Study Management Meetings).
  
• Experience in working with and overseeing Contract Research Organizations (CROs)