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Legend Biotech is seeking a Director, 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 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 the collaborating 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 staff a small number of Clinical Trial Managers is essential.
Key Responsibilities
#LI-RT1
#LI-Hybrid
Full Time
$155k-215k (estimate)
03/16/2024
07/10/2024
The job skills required for Director, Clinical Operations include Leadership, Clinical Operations, Clinical Research, Planning, Clinical Trial, Collaboration, etc. Having related job skills and expertise will give you an advantage when applying to be a Director, Clinical Operations. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Director, Clinical Operations. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for Director, Clinical Operations positions, which can be used as a reference in future career path planning. As a Director, Clinical Operations, it can be promoted into senior positions as a Critical Care Director that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Director, Clinical Operations. You can explore the career advancement for a Director, Clinical Operations below and select your interested title to get hiring information.