Legend Biotech US
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.
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
Director of 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. Key Responsibilities Direct end-to-end clinical trial management activities domestically and globally. Lead clinical operation execution of complex protocols within a matrix environment. Define project timelines & deliverables, working closely with the Sr. Director of Clinical Operations, Project Management, and cross-functional team. Collaborate with PM to create study project plans, 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 team members to lead monthly process improvement meetings for optimal clinical operation performance. Help develop new work streams, SOPs, study template, tracking tools, dashboards to support optimal clinical operation performance. Report on all aspects of the study progress at a granular level to operations management. Experience in working with and overseeing Contract Research Organizations (CROs) and other external vendors is required. Oversee vendor selection process, negotiates contracts and budgets with sites and vendors and presents to the executive study team for approval. Collaborate with the Sr. Director of Clinical operations to analyze multiple study budgets across programs for cost savings. Collaborate with Sr. Director of Operations and study leadership team to create preferred vendor list for clinical development. Management/oversight of external vendor deliverables reports and budgets. Participates in all CRO study related calls and meeting, tracks actions, escalates issues and oversees all aspects of daily study operations. Collaborates in the preparation and/or review of study-related documents. Help develop and implement SOPs in accordance with regulatory guidelines and GCP. 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 the assigned clinical trials are executed in compliance with FDA and ICH/GCP guidelines/regulations and SOPs. Provides study-specific training and leadership to clinical research staff, including CRO, sites and other contract personnel. Has critical thinking skills for problem solving and have the lateral and strategic thinking capacity to drive the study(ies) and understand the upstream, downstream and lateral implications of decisions that affect study outcomes and timelines. Comfortable multi-tasking in a fast-paced small company startup environment and able to adjust workload based upon changing priorities. Excellent team player; 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. Experience leading the planning and management of CAR-T studies preferred. 10+ years of pharmaceutical, biotech or CRO related/ oncology clinical research experience. Excellent organizational skills, ability to manage multiple tasks and meticulous attention to detail. Regulatory authority inspection experience a plus. Ability to travel as necessary (approximately 10 – 15 %). Effective oral, written and interpersonal communication skills. Strong communication and presentation skills. Forward and Critical thinker. 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 preferred. Excellent working knowledge GCP, FDA and ICH Guidelines. EEO Statement Legend Biotech is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce.
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Director of 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. Key Responsibilities Direct end-to-end clinical trial management activities domestically and globally. Lead clinical operation execution of complex protocols within a matrix environment. Define project timelines & deliverables, working closely with the Sr. Director of Clinical Operations, Project Management, and cross-functional team. Collaborate with PM to create study project plans, 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 team members to lead monthly process improvement meetings for optimal clinical operation performance. Help develop new work streams, SOPs, study template, tracking tools, dashboards to support optimal clinical operation performance. Report on all aspects of the study progress at a granular level to operations management. Experience in working with and overseeing Contract Research Organizations (CROs) and other external vendors is required. Oversee vendor selection process, negotiates contracts and budgets with sites and vendors and presents to the executive study team for approval. Collaborate with the Sr. Director of Clinical operations to analyze multiple study budgets across programs for cost savings. Collaborate with Sr. Director of Operations and study leadership team to create preferred vendor list for clinical development. Management/oversight of external vendor deliverables reports and budgets. Participates in all CRO study related calls and meeting, tracks actions, escalates issues and oversees all aspects of daily study operations. Collaborates in the preparation and/or review of study-related documents. Help develop and implement SOPs in accordance with regulatory guidelines and GCP. 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 the assigned clinical trials are executed in compliance with FDA and ICH/GCP guidelines/regulations and SOPs. Provides study-specific training and leadership to clinical research staff, including CRO, sites and other contract personnel. Has critical thinking skills for problem solving and have the lateral and strategic thinking capacity to drive the study(ies) and understand the upstream, downstream and lateral implications of decisions that affect study outcomes and timelines. Comfortable multi-tasking in a fast-paced small company startup environment and able to adjust workload based upon changing priorities. Excellent team player; 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. Experience leading the planning and management of CAR-T studies preferred. 10+ years of pharmaceutical, biotech or CRO related/ oncology clinical research experience. Excellent organizational skills, ability to manage multiple tasks and meticulous attention to detail. Regulatory authority inspection experience a plus. Ability to travel as necessary (approximately 10 – 15 %). Effective oral, written and interpersonal communication skills. Strong communication and presentation skills. Forward and Critical thinker. 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 preferred. Excellent working knowledge GCP, FDA and ICH Guidelines. EEO Statement Legend Biotech is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce.
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