Senior Clinical Trial Associate

Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life‑threatening diseases. Headquartered in Bridgewater, New Jersey, we are advancing the next generation of cell therapy through a portfolio of innovative technologies, including autologous, allogeneic, and in vivo cell therapy approaches. Our research spans chimeric antigen receptor T‑cell (CAR‑T), T‑cell receptor (TCR‑T), natural killer (NK) cell‑based therapies, and other emerging platforms designed to transform the treatment of serious diseases. From our global network of research and development sites, we are committed to discovering and developing safe, effective, and cutting‑edge therapies for patients worldwide. Legend Biotech entered into a global collaboration agreement with Johnson & Johnson to jointly develop and commercialize CARVYKTI® (ciltacabtagene autoleucel; cilta‑cel). Through this strategic partnership, we combine complementary expertise and capabilities to advance innovative immunotherapies for patients living with multiple myeloma. Legend Biotech is seeking the Senior Clinical Trial Associate as part of the Clinical Operations team basedin Somerset, NJ . Location Remote 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 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. Oversee the preparation, organization, and maintenance of trial documentation, including regulatory files, Trial Master Files (TMFs/eTMFs), and study correspondence. Ensure documentation is current, complete, and compliant with ICH‑GCP and company SOPs. Assist with the planning, start‑up, execution, and close‑out of clinical trials, including coordination with clinical sites and support of protocol and regulatory compliance activities. Assist with the preparation, submission, and tracking of regulatory and IRB/IEC documents. Maintain working knowledge of applicable regulations and standards to support ongoing study compliance. Schedule and coordinate study meetings, including investigator meetings, site visits, and internal team meetings. Prepare meeting agendas, document minutes, track action items, and follow up to ensure timely completion. Assist in tracking trial progress, including site activation, enrollment, monitoring activities, and key study milestones. Prepare and maintain study status reports and trackers for internal and external stakeholders. Support data management activities, including query tracking and data reconciliation, in collaboration with Data Management. Serve as a key liaison between the clinical trial team, vendors, CROs, and investigational sites to ensure clear and timely communication. Assist with vendor oversight by tracking deliverables, timelines, and resolving operational issues. Proactively identify operational issues and risks, propose solutions, and elevate to the Senior Clinical Trial Manager or Clinical Operations leadership as appropriate. Contribute to the development and continuous improvement of clinical operations processes and best practices. Provide guidance and mentorship to junior CTAs, sharing best practices and contributing to team capability building. Requirements Bachelor’s degree in life sciences, clinical research, or a related field. Relevant certifications (e.g., CRC, CRA) are a plus. 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 trial experience required; cell therapy and/or CAR‑T experience strongly preferred. 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 fast‑paced 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. Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and familiarity with eTMF and EDC platforms.

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• Li-Hybrid

Please note: These benefits are offered exclusively to permanent full‑time employees. Contractors are not eligible for benefits through Legend Biotech. Applicants must be authorized to work in the United States. As part of our commitment to maintaining a lawful workforce and ensuring compliance with federal employment regulations, we participate in the E‑Verify program. If you are selected for employment, you will be required to complete the Form I‑9 process, and your employment eligibility will be verified through E‑Verify in accordance with applicable federal law. We are committed to providing a fair, transparent, and welcoming hiring experience for all candidates. 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. I (the candidate) enter into this Non-Disclosure Agreement (the “Agreement”) with Legend Biotech USA Inc. (the “Company”), effective as of the date of my acknowledgement below, for the purpose of enabling the Company to evaluate a possible employment relationship with me. Access to Company Confidential Information. I acknowledge that for the sole and limited purpose of evaluating a possible employment relationship with me, the Company might disclose, or enable me to have access to, certain Confidential Information of the Company, as defined below. I agree that, except for purposes of evaluating a possible employment relationship with the Company or as expressly authorized in writing by the Company, I will (a)not use or disclose any Confidential Information; (b)keep all Confidential Information confidential at all times; and (c)not copy, reproduce or modify any Confidential Information. Definition of “Confidential Information.” For purposes of this Agreement, “Confidential Information” shall mean any and all information and materials provided to me by the Company, including without limitation, inventions, trade secrets, software code, product development and marketing strategies, ideas, processes, formulas, know‑how, unpublished financial information, business plans, contractual relationships with third parties and operating strategies; memoranda, notes, records, drawings, manuals, disks, or other documents and media; and all embodiments, copies, extracts, and summaries thereof; provided, however, that “Confidential Information” shall not include information that: (a) is generally known or available to the public, or (b) is furnished to me by a third party who obtained such information using lawful means and without any restrictions on disclosure. Third Party Information. I agree that during the course of communications with the Company pursuant to this Agreement or in connection with my application and interviews for employment with the Company, I will not make any unauthorized use or disclosure to the Company of any confidential or proprietary information or trade secrets of any other person or entity to whom I have an obligation of confidentiality with respect to such information, including any current or former employer. I further agree not to provide to the Company any materials or documents of any third party that are not generally available to the public. Remedies for Breach. I acknowledge that in the event of any breach of this Agreement, the Company will not have an adequate remedy in money or damages, and therefore the Company shall be entitled to obtain temporary, preliminary and/or permanent injunctive relief to redress any such breach, from any court of competent jurisdiction, and that the Company’s right to obtain such relief shall not limit its right to obtain other available remedies. General. The interpretation and enforcement of this Agreement shall be governed by the laws of the State of California. This Agreement constitutes the entire agreement between the parties concerning the subject matters hereof; it supersedes any and all prior agreements or representations, written or oral, with respect to its subject matters; and it cannot be modified except in a written agreement signed by the Company. Please print your name if you agree to the terms and conditions set forth in the applicant Non-Disclosure Agreement. #J-18808-Ljbffr Legend Biotech US