Legend Biotech USA
Overview
Legend Biotech is seeking a
Director of Clinical Operations
as part of the
Clinical Operations
team based in
Somerset, NJ . The Director, Clinical Operations is responsible for leading the planning, management, and oversight of Legend Biotech pipeline studies. The role includes all aspects of study conduct, CRO oversight, and serves as a point of contact for clinical study project management, communications, and daily operations for the clinical INDs held by Legend Biotech USA, Inc. Experience in end-to-end management of clinical trial conduct, the pharmaceutical industry, clinical drug development, and FDA/ICH regulatory requirements is essential. The position collaborates 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. The position involves partnering with the Sr. Director of Clinical Research Operations and Data Analytics Strategy and supporting 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. The role ensures program consistency across studies, drives operational excellence through process improvement, and represents the clinical trial operations function in internal and external meetings. The ability to mentor and develop new clinical operations team members (Sr. CTMs, CTMs, CTAs) is required. Key Responsibilities
Direct end-to-end clinical trial management activities domestically and globally, including ownership of study planning, start-up, and oversight of study execution within clinical operations. Lead clinical operation execution of complex protocols within a matrix environment (Project Management, Safety, outsourcing and vendor management, Data Management, Statistics, Clinical Supplies, Safety, etc.). Define project timelines and deliverables, working with the Sr. Director of Clinical Operations, Project Management, and cross-functional teams to align with company strategy and drive performance. Collaborate with PM to create study project plans and end-to-end study timelines for execution of clinical trials from IND submission activities to first site activation. Collaborate with tech ops, procurement, legal, project management, finance, and other cross-functional teams to lead monthly process improvement meetings for optimal clinical operation performance. Develop new work streams, SOPs, study templates, tracking tools, and dashboards to support clinical operation performance. Report on study progress to operations management with regular, granular updates. Prepare and present project reports as required. Plan, execute, and lead study-specific meetings as needed. Oversee CROs and external vendors, including vendor selection, contract budgets, and presenting to the executive study team for approval. Analyze multiple study budgets across programs for cost savings; collaborate with Sr. Director of Clinical Operations to create a preferred vendor list and lead vendor performance assessments for continuous improvement. Manage external vendor deliverables, budgets, and study invoice tracking. Participate in CRO study calls and meetings, track actions, escalate issues, and oversee daily study operations. Identify risks and develop mitigations or escalate as appropriate. Collaborate in the preparation and review of study-related documents (e.g., Study Operations Plan, Monitoring Plan, Pharmacy Manual, Informed Consent, Laboratory Manual, CRF Guidelines, tools, and manuals). Develop and implement SOPs in accordance with regulatory guidelines and GCP. Ensure audit-ready clinical trial documentation, manage internal process audits, vendor and study site quality audits, and regulatory inspections. Contribute to writing and reviewing study protocols, informed consents, and amendments. Ensure trials are conducted in compliance with FDA and ICH/GCP guidelines and SOPs. Provide study-specific training and leadership to clinical research staff, including CROs, sites, and contract personnel. Demonstrate critical thinking for problem solving and strategic thinking to drive study outcomes and timelines. Adaptable, fast-paced team member who can manage shifting priorities; capable of filling functional gaps in a small organization. Excellent teamwork and willingness to contribute across functions. Requirements
Bachelor’s degree in a scientific or healthcare discipline; advanced degree preferred. Experience leading planning and management of CAR-T studies preferred; ability to multi-task and meet high-performance demands. 10+ years in pharmaceutical, biotech, CRO, or oncology clinical research experience (15+ years preferred). Strong organizational skills with the ability to manage multiple tasks and attention to detail. CRO/vendor oversight experience required; project management experience a plus. Regulatory authority inspection experience a plus; ability to travel as necessary (approximately 10–15%). Excellent oral, written, and interpersonal communication skills; strong presentation skills. Forward and critical thinker; SOP development preferred. Strong project management skills and ability to multitask; computer literacy (MS Word, Excel, PowerPoint, MS Project). Oncology therapeutic experience preferred; strong knowledge of GCP, FDA, and ICH guidelines. Benefits and EEO
Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, NJ, we offer a best-in-class benefits package designed to support well-being, financial stability, and long-term career growth. Highlights include medical, dental, and vision insurance; 401(k) with company match; equity and stock options for eligible roles; eight weeks of paid parental leave after three months; and a comprehensive PTO policy (15 vacation days, 5 personal days, 5 sick days, 11 U.S. national holidays, and 3 floating holidays). Additional benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability, legal assistance, and supplemental plans. We also provide commuter benefits, family planning resources, well-being initiatives, and recognition programs to support a positive culture. EEO Statement Legend Biotech is an equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is Legend’s policy to provide equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law. Employment is at-will and may be terminated at any time with or without cause or notice. Legend Biotech maintains a drug-free workplace.
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Legend Biotech is seeking a
Director of Clinical Operations
as part of the
Clinical Operations
team based in
Somerset, NJ . The Director, Clinical Operations is responsible for leading the planning, management, and oversight of Legend Biotech pipeline studies. The role includes all aspects of study conduct, CRO oversight, and serves as a point of contact for clinical study project management, communications, and daily operations for the clinical INDs held by Legend Biotech USA, Inc. Experience in end-to-end management of clinical trial conduct, the pharmaceutical industry, clinical drug development, and FDA/ICH regulatory requirements is essential. The position collaborates 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. The position involves partnering with the Sr. Director of Clinical Research Operations and Data Analytics Strategy and supporting 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. The role ensures program consistency across studies, drives operational excellence through process improvement, and represents the clinical trial operations function in internal and external meetings. The ability to mentor and develop new clinical operations team members (Sr. CTMs, CTMs, CTAs) is required. Key Responsibilities
Direct end-to-end clinical trial management activities domestically and globally, including ownership of study planning, start-up, and oversight of study execution within clinical operations. Lead clinical operation execution of complex protocols within a matrix environment (Project Management, Safety, outsourcing and vendor management, Data Management, Statistics, Clinical Supplies, Safety, etc.). Define project timelines and deliverables, working with the Sr. Director of Clinical Operations, Project Management, and cross-functional teams to align with company strategy and drive performance. Collaborate with PM to create study project plans and end-to-end study timelines for execution of clinical trials from IND submission activities to first site activation. Collaborate with tech ops, procurement, legal, project management, finance, and other cross-functional teams to lead monthly process improvement meetings for optimal clinical operation performance. Develop new work streams, SOPs, study templates, tracking tools, and dashboards to support clinical operation performance. Report on study progress to operations management with regular, granular updates. Prepare and present project reports as required. Plan, execute, and lead study-specific meetings as needed. Oversee CROs and external vendors, including vendor selection, contract budgets, and presenting to the executive study team for approval. Analyze multiple study budgets across programs for cost savings; collaborate with Sr. Director of Clinical Operations to create a preferred vendor list and lead vendor performance assessments for continuous improvement. Manage external vendor deliverables, budgets, and study invoice tracking. Participate in CRO study calls and meetings, track actions, escalate issues, and oversee daily study operations. Identify risks and develop mitigations or escalate as appropriate. Collaborate in the preparation and review of study-related documents (e.g., Study Operations Plan, Monitoring Plan, Pharmacy Manual, Informed Consent, Laboratory Manual, CRF Guidelines, tools, and manuals). Develop and implement SOPs in accordance with regulatory guidelines and GCP. Ensure audit-ready clinical trial documentation, manage internal process audits, vendor and study site quality audits, and regulatory inspections. Contribute to writing and reviewing study protocols, informed consents, and amendments. Ensure trials are conducted in compliance with FDA and ICH/GCP guidelines and SOPs. Provide study-specific training and leadership to clinical research staff, including CROs, sites, and contract personnel. Demonstrate critical thinking for problem solving and strategic thinking to drive study outcomes and timelines. Adaptable, fast-paced team member who can manage shifting priorities; capable of filling functional gaps in a small organization. Excellent teamwork and willingness to contribute across functions. Requirements
Bachelor’s degree in a scientific or healthcare discipline; advanced degree preferred. Experience leading planning and management of CAR-T studies preferred; ability to multi-task and meet high-performance demands. 10+ years in pharmaceutical, biotech, CRO, or oncology clinical research experience (15+ years preferred). Strong organizational skills with the ability to manage multiple tasks and attention to detail. CRO/vendor oversight experience required; project management experience a plus. Regulatory authority inspection experience a plus; ability to travel as necessary (approximately 10–15%). Excellent oral, written, and interpersonal communication skills; strong presentation skills. Forward and critical thinker; SOP development preferred. Strong project management skills and ability to multitask; computer literacy (MS Word, Excel, PowerPoint, MS Project). Oncology therapeutic experience preferred; strong knowledge of GCP, FDA, and ICH guidelines. Benefits and EEO
Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, NJ, we offer a best-in-class benefits package designed to support well-being, financial stability, and long-term career growth. Highlights include medical, dental, and vision insurance; 401(k) with company match; equity and stock options for eligible roles; eight weeks of paid parental leave after three months; and a comprehensive PTO policy (15 vacation days, 5 personal days, 5 sick days, 11 U.S. national holidays, and 3 floating holidays). Additional benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability, legal assistance, and supplemental plans. We also provide commuter benefits, family planning resources, well-being initiatives, and recognition programs to support a positive culture. EEO Statement Legend Biotech is an equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is Legend’s policy to provide equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law. Employment is at-will and may be terminated at any time with or without cause or notice. Legend Biotech maintains a drug-free workplace.
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