This is a hybrid position requiring on-site presence for 3+ days per week and remote work for 2 days from home. The role can be based in Armonk, NY, Basking Ridge, NJ, Cambridge, Mass, Uxbridge, UK or Dublin, Ireland. A fully remote role is not possible for this position.
Responsibilities
* Leadership and strategic management of one or more therapeutic areas in Clinical Trial Management (CTM)
* Directing clinical operations activities and decisions, including quality, timelines, and costs related to the conduct of clinical research studies
* Ensuring compliance with applicable regulations, ICH/GCP regulations, and company Standard Operating Procedures (SOP's) within assigned TA(s)
This role will report to the Head of CTM and will interface and partner with senior-level management across the TA and functions to enable efficient delivery of the assigned TA.
Key Skills
* Partnership with Therapeutic Area Head and Global Program Heads to review TA progress and project status
* Responsible and accountable for the successful operational delivery of all studies in the TA within the Clinical Development Plan (CDP)
* Contribution to the development of program and clinical trial operational strategy, including feasibility, timelines, cost estimates, and participation in strategy committees
This role requires a minimum of 15 years' experience in clinical operations, with at least 10 years of functional leadership, people management, leadership, and mentoring experience, as well as expertise in obesity, muscle, and metabolism, and knowledge of GCP and ICH guidelines.
Requirements
* Bachelor's degree; advanced degree highly desirable
* Experience leading complex, global clinical trials with outsourced CRO/FSP model(s)
* Exceptional project management, cross-functional team leadership, and organizational skills
Please note that certain background checks will form part of the recruitment process.