Associate Director/Director, Clinical Operations

Company Information

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 and natural killer (NK) cell-based immunotherapy. 

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) in 2017. 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 Director/Director, Clinical Operations as part of the Clinical Operations team based in Somerset, NJ (Remote). 

Role Overview

The Associate Director, Clinical Operations is responsible for leading, managing and providing oversight across all Legend Pipeline studies. This individual must be able to work and lead in a small, fast-paced environment while also wearing multiple hats at any given time as the needs of the organization change and evolve. This position requires a high-performing contributor with strong leadership and people management skills. The Director of Clinical Operations will lead & mentor the Clinical Operations team and collaborate with cross functional team to identify clinical trial operational risks and develop mitigation strategies to ensure optimal and efficient clinical trial execution. 

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. This position requires experience and leading study/project management to create study project plans, and end-to end-study timelines for execution of clinical trials from IND submission activities to first site activation/FPI. 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.

The position involves working closely with the Sr. Director of Clinical Research Operations 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.

Experience and knowledge of end-to-end management of clinical trial conduct, knowledge of the pharmaceutical industry and an understanding of clinical drug development, CAR-T, cellular/gene industry landscape, clinical trials operations and FDA/ICH regulatory requirements is essential. The ability to manage, mentor, oversee develop new clinical staff is essential since this position will have multiple direct reports.

Key Responsibilities  

• Direct end-to-end (IND enabling to FPI) clinical trial Operations activities domestically and globally: i.e. lead and take ownership in all aspects of Study Operations for CAR-T Studies in a matrix environment.
  
• Responsible for the overall success of the clinical study programs
  
• Ensures the assigned clinical trials are executed in compliance with FDA and ICH/GCP guidelines/regulations and SOPs. Ensures audit-ready condition of clinical trial documentation including central clinical files. 
  
• 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., Senior and Mid-level management Study Management Meetings).
  
• Supports the Development of strategic plans for clinical trial operations, ensuring alignment with the company's overall goals and objectives.
  
• Collaborate with the cross-functional "core" teams to integrate clinical operations strategies into broader development plans.
  
• Define project timelines & deliverables, by working closely with the Sr. Director of Clinical Operations, Sr. CTMs, and cross-functional team for execution of clinical trials from IND submission activities to first site activation/FPI 
  
• Collaborates in the preparation and/or r