Legend Biotech
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 a Senior Clinical Trial Associate as part of the Clinical Operations team based remotely.
Role Overview
We are seeking a highly skilled and motivated Senior Clinical Trial Associate (Sr. CTA) to join our growing Clinical Operations team to support early-stage clinical development. The Sr. CTA will play a critical role in the execution of complex Phase I/II CAR-T oncology clinical trials by providing high-quality operational, administrative, and coordination support.
The ideal candidate will have substantial experience in clinical trial operations and administration, with a strong understanding of clinical trial processes, regulatory requirements, and GCP. This role is critical to ensuring the efficient execution of clinical trials, maintaining regulatory compliance, and providing operational support to cross functional study teams.
Key Responsibilities
Clinical Trial Operations Support
• Provide cross-functional administrative and operational support for study team meetings, advisory boards, investigator meetings, and other study-related forums.
• Support Senior Clinical Trial Managers in the day-to-day execution of complex Phase I and Phase II CAR-T oncology trials, ensuring all activities are conducted in compliance
with ICH-GCP and applicable regulatory requirements.
Documentation & TMF Management
• Oversee the preparation, organization, and maintenance of trial documentation, including regulatory files, Trial Master Files (TMFs/eTMFs), and study correspondence.
Requirements
Education
• Bachelor’s degree in life sciences, clinical research, or a related field.
• Relevant certifications (e.g., CRC, CRA) are a plus.
Experience
• Minimum of 3–5 years of experience as a Clinical Trial Associate or in a similar clinical research role.
• Demonstrated experience supporting trial coordination, regulatory documentation, and site management activities.
• Oncology and/or Autoimmune Disease trial experience required; cell therapy and/or CAR-T experience strongly preferred.
Skills & Competencies
• Strong understanding of ICH-GCP, regulatory requirements, and clinical trial processes.
• Proficiency with CTMS, eTMF, and EDC systems.
• Excellent organizational skills with the ability to manage multiple priorities in a fastpaced environment.
• Strong written and verbal communication skills.
• Detail-oriented with strong analytical and problem-solving skills.
• Ability to work independently and collaboratively within cross-functional teams.
Technical Skills
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and familiarity with eTMF and EDC platforms.
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Please note: These benefits are offered exclusively to permanent full-time employees. Contractors are not eligible for benefits through Legend Biotech.
EEO Statement
It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances.
Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company.