Senior Clinical Trial Manager

Company Information

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. Job duties also include CRO oversight and point of contact for clinical study project management, communications, and daily operations for the clinical INDs held by Legend Biotech USA, Inc.
• 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 : i.e. experience in all aspects of study start-up and oversight of study execution and close out
• 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. Effective, consistent & regular tracking of project (s).
• Collaborates with following groups across the trial program : Data Management, Statistics, Clinical Supplies, Safety, etc.
• Participates in all CRO study related calls and meeting, 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.
• Ability to identify issues and risks, develops and manage mitigations and / or escalate risks appropriately.
• Utilizes project management skills to ensure consistency in processes and drive Clinical Operations performance. Efficient process and system thinker
• Daily interaction with the study CRO project manager and Sr. Clinical Trial Manager
• Collaborates in the preparation and / or review of study-related documents (e.g., Study Operations Plan, Monitoring Plan, Pharmacy Manual, Informed Consent, Laboratory Manual, CRF Completion Guidelines, study tools / worksheets and other study-specific documents or manuals).
• 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 executed in compliance with FDA and ICH / GCP guidelines / regulations and SOPs.
• Ensure Trial Master Files (eTMFs) are properly maintained.
• Ability to manage and collaborate on complex protocols within a matrix environment (Data Management, Safety, outsourcing and vendor alliance management).
• 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 start-up environment and able to adjust workload based upon changing priorities.
• Adaptable / flexible, self-starter (willing and able to adjust to multiple demands, sometimes beyond job descriptions and shifting priorities;

ability to meet day-to-day challenges with confidence and professionalism)

• 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 7. Demonstrated ability to multi-task, wear multiple hats and manage high performance demands
• Excellent organizational skills, ability to manage multiple tasks and meticulous attention to detail
• Project Management (CRO / biotech) experience a plus
• Regulatory authority inspection experience a plus
• Experience managing multiple studies
• Experience managing complex or global trials preferred familiarity with regulatory process in global studies
• Ability to travel as necessary (approximately 10 - 15 %)
• Effective oral, written and interpersonal communication skills
• Strong communication skills
• Sop development preferred
• 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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Legend Biotech is a proud 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 ensure 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.

Legend Biotech maintains a drug-free workplace.