Director, Clinical Operations

Legend Biotech is seeking a Director, 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. 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 Sr. Director of Clinical Research 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. This position requires the collaborating with project management to support 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.  In addition, the position will ensure program consistency across studies, drive research and operational excellence through process improvement, and represent the clinical trial operation function at internal and external meetings.

Experience and knowledge of end-to-end management of clinical trial conduct, knowledge of the pharmaceutical industry and an understanding of clinical drug development, cellular/gene industry landscape, clinical trials operations and FDA/ICH regulatory requirements is essential. The ability to manage, mentor, oversee develop new clinical staff a small number of Clinical Trial Managers is essential.

Key Responsibilities  

• Direct end-to-end clinical trial management activities domestically and globally: i.e. lead and take ownership in all aspects 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 alliance management Data Management, Statistics, Clinical Supplies, Safety, etc.).
• Define project timelines & deliverables, working closely with the Sr. Director of Clinical Operations, Project Management, and cross-functional team and assure that they are consistent with company strategy and drive clinical operations performance.
• 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.
• Helps with developing 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. Effective, consistent & regular tracking of project (s). Prepare and present project reports as required. Plans, executes, and leads study-specific meetings as needed (e.g., Study Management Meetings). 
• 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. Lead vendor performance assessment for continuous process improvement.
• Management/oversight of external vendor deliverables reports and budgets. Study invoice payment tracking and projections.
• Participates in all CRO study related calls and meeting, tracks actions, escalates issues and oversees all aspects of daily study operations. Ability to identify issues and risks develops and manage mitigations and/or escalate risks appropriately.
• 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). 
• Help develop and implement SOPs in accordance with regulatory guidelines and GCP.
• Ensures audit-ready condition of clinical trial documentation including central clinical files. Prepare and follow-up of internal process audits, vendor, and study site quality audits, as well as regulatory authority inspections.
• 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.
• Adaptable / flexible, self-starter (willing and able to adjust to multiple demands and shifting priorities; ability to meet day-to-day challenges with confidence and professionalism).
• Excellent team player; willingness and ability to fill functional gaps in a small organization.
• Working closely with the Sr. Director of Clinical Research 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.
• Mentoring and management of Clinical Trial Managers (CTM).

Requirements

• Minimum degree requirements of a Bachelor’s Degree (BA, BS) in scientific or health care discipline. Advance Degree Preferred.
• Experience leading the planning and management of CAR-T studies preferred.  
• Demonstrated ability to multi-task and manage high performance demands.
• 10+ years of pharmaceutical, biotech or CRO related/ oncology clinical research experience. (15+ years preferred).
• Excellent organizational skills, ability to manage multiple tasks and meticulous attention to detail.
• CRO/Vendor  oversight experience required.
• Project Management (CRO/biotech) experience a plus.
• Regulatory authority inspection experience a plus.
• Ability to travel as necessary (approximately 10 – 15 %).

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