Associate Director/Director, Clinical Operations

Legend Biotech is seeking an Associate Director/Director, Clinical Operations as part of the Clinical Operations team based in Somerset, NJ (Remote). 

Role Overview

The Associate Director, Clinical Operations is responsible for leading, managing and providing oversight across all Legend Pipeline studies. This individual must be able to work and lead in a small, fast-paced environment while also wearing multiple hats at any given time as the needs of the organization change and evolve. This position requires a high-performing contributor with strong leadership and people management skills. The Director of Clinical Operations will lead & mentor the Clinical Operations team and collaborate with cross functional team to identify clinical trial operational risks and develop mitigation strategies to ensure optimal and efficient clinical trial execution. 

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. This position requires experience and leading study/project management to create study project plans, and end-to end-study timelines for execution of clinical trials from IND submission activities to first site activation/FPI. 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.

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.

Experience and knowledge of end-to-end management of clinical trial conduct, knowledge of the pharmaceutical industry and an understanding of clinical drug development, CAR-T, cellular/gene industry landscape, clinical trials operations and FDA/ICH regulatory requirements is essential. The ability to manage, mentor, oversee develop new clinical staff is essential since this position will have multiple direct reports.

Key Responsibilities  

• Direct end-to-end (IND enabling to FPI) clinical trial Operations activities domestically and globally: i.e. lead and take ownership in all aspects of Study Operations for CAR-T Studies in a matrix environment.
  
• Responsible for the overall success of the clinical study programs
  
• Ensures the assigned clinical trials are executed in compliance with FDA and ICH/GCP guidelines/regulations and SOPs. Ensures audit-ready condition of clinical trial documentation including central clinical files. 
  
• 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., Senior and Mid-level management Study Management Meetings).
  
• Supports the Development of strategic plans for clinical trial operations, ensuring alignment with the company's overall goals and objectives.
  
• Collaborate with the cross-functional "core" teams to integrate clinical operations strategies into broader development plans.
  
• Define project timelines & deliverables, by working closely with the Sr. Director of Clinical Operations, Sr. CTMs, and cross-functional team for execution of clinical trials from IND submission activities to first site activation/FPI 
  
• Collaborates in the preparation and/or review of study-related documents (e.g., study protocols, informed consents and amendments, Study Operations Plan, Monitoring Plan, Pharmacy Manual, Informed Consent, Laboratory Manual, CRF Completion Guidelines, study tools/worksheets and other study-specific documents or manuals). 
• Director will drive clinical Operations excellence by playing a critical role in Clinical Trial Operations Efficiency and optimization. 
  
• Work with cross-functional teams and external vendors to identify clinical trial operational risks and develop mitigation strategies to ensure quality delivery of the clinical trial to support optimal and efficient clinical trial execution.  
  
• Collaborate with tech ops, procurement, legal, project management, finance, and other cross-functional team members to support monthly process improvement meetings for optimal clinical operation performance. 
  
• Create and Manage study trial execution RACI to support overall trial execution and operational excellence. 
  
• Contribute to Clinical Operations functional initiatives for role clarity and institution of best practices.
• Manage and build a high-performing clinical operations team (Multiple Sr. CTMs, CTA and eTMF specialist). Duties include hiring, onboarding, training, and development of staff to oversee studies.
  
• Lead, develop and manage study operation manual, new work-streams, SOPs, study template, tracking tools, dashboards to support optimal clinical operation performance. 
  
• Provides study-specific training and leadership to clinical research staff, including CRO, sites and other study personnel to support clinical trial execution and optimization.
  
• Oversee vendor selection process, management, of Contract Research Organizations (CROs) and vendors involved in clinical trial Operation (CRO, Central Lab, etc).
• Participates in CRO and vendor 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.
• Negotiates vendor contracts / budgets and presents to the executive study team for approval.
• Review and confirm CRO and site payment invoices.
• Lead vendor performance assessment for continuous process improvement
• Management/oversight of external vendor deliverables reports and budgets.
• Collaborate with Sr. Director of Operations and study leadership team to create preferred vendor list for clinical development.
• 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.
• 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.
• Comfortable multi-tasking in a fast-paced small company startup environment and able to adjust workload based upon changing priorities
• Performs other duties as required.

Requirements

• Minimum degree requirements of a bachelor’s degree (BA, BS) in scientific or health care discipline. Advance Degree Preferred
• Oncology Therapeutic Experience required.
• 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 5 – 15 %)
• Effective oral, written and interpersonal communication skills.
• Strong communication and presentation skills
• Forward and Critical thinker
• 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)
• Excellent working knowledge GCP, FDA and ICH Guidelines

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