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 Sr. Clinical Trial Manager as part of the Clinical Operations team based Remote.
Role Overview
The Sr. Clinical Trial Manager will provide management and oversight of the Legend Biotech pipeline studies. The Sr. CTM will be responsible for all aspects of study set up, management and oversight of Legend Biotech pipeline studies. Job duties also include CRO oversight and a point of contact for clinical study project management, communications, 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 Associate Director of Clinical 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. In addition, the position will ensure program consistency across studies, drive research and operational excellence through process improvement, SOP creation and development and represent the clinical trial operation function at internal and external meetings.
Key Responsibilities
- Responsible for all aspects of study set up, management and oversight of Legend Biotech pipeline studies.
- Experience in working with and overseeing Contract Research Organizations (CROs) and other external vendors is required.
- Demonstrated ability to drive end to end clinical trial activities.
- Develop and manage comprehensive study timelines and metrics; clinical operation efficiency tools, management/oversight of external vendor deliverables reports and budgets.
- Report on all aspects of the study progress at a granular level to Operations management.
- Collaborates with following groups across the trial program: Data Management, Statistics, Clinical Supplies, Safety, etc.
- Participates in all CRO study related calls and meetings, tracks actions, escalates issues and oversees all aspects of daily study operations.
- Lead and co-lead internal study operational calls and meetings.
- Collaborate with the Director of Clinical Operations on study budget development, financial forecasting/budgeting management and vendor & site payments.
- Utilizes project management skills to ensure consistency in processes and drive Clinical Operations performance.
- Daily interaction with the study CRO project manager and Sr. Clinical Trial Manager.
- Collaborates in the preparation and/or review of study-related documents.
- Ensures audit-ready condition of clinical trial documentation including central clinical files.
- Collaborates in the writing and review of study protocols, informed consents and amendments.
- Ensures compliance with FDA and ICH/GCP guidelines/regulations and SOPs.
- Ability to manage and collaborate on complex protocols within a matrix environment.
- Excellent team player but also independently without significant oversight.
- Strong self-starter and hardworking individual, willingness and ability to fill functional gaps in a small organization.
Requirements
- Minimum degree requirements of a Bachelor’s Degree (BA, BS) in scientific or health care discipline preferred.
- 7+ years of managing studies at a pharmaceutical, biotech or CRO.
- 3+ years of oncology clinical research experience required.
- Experience working in small biotech/pharma environment.
- Cellular/Gene therapy (CAR-T) experience a plus.
- CRO/Multiple vendor oversight on complex studies experience required.
- Excellent organizational skills, ability to manage multiple tasks and meticulous attention to detail.
- Ability to travel as necessary (approximately 10 – 15 %).
- Effective oral, written and interpersonal communication skills.
- Strong organizational and project management skill and the ability to multitask.
- Computer literacy required (MS word, MS excel, MS PowerPoint and MS Project).
- Oncology Therapeutic Experience required.
- Excellent working knowledge GCP, FDA and ICH Guidelines.
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