Job Summary
We are seeking an Executive Director Therapeutic Area Operations Leader to lead the strategic management of one or more therapeutic areas in Clinical Trial Management (CTM).
The ideal candidate will have 15+ years of clinical operations experience, including 10+ years of functional leadership, people management, and mentoring experience. They must also have expertise in Obesity, Muscle, and Metabolism, as well as in-depth knowledge of GCP and ICH.
This role involves directing clinical operations activities and decisions, including quality, timelines, and costs related to the conduct of clinical research studies. The successful candidate will be responsible for line management of staff, recruitment, retention, professional development, and performance management.
The Executive Director TA Operations Leader will partner with senior level management across the TA and functions to enable efficient delivery of the assigned TA. They will provide sponsorship, leadership, and direction for departmental initiatives and contribute functional area expertise to the development of the program and clinical trial operational strategy.
The ideal candidate will have excellent project management, cross-functional team leadership, and organizational skills. They must be able to make decisions, set priorities, and share resources based upon an enterprise mindset, ensuring the benefit to the whole organization.
In this role, you will:
* Partner with the Therapeutic Area Head and Global Program Heads to review TA progress and project status
* Be responsible and accountable for the successful operational delivery of all studies in the TA within the Clinical Development Plan (CDP)
* Contribute functional area expertise to the development of the program and clinical trial operational strategy
* Ensure delivery of quality operational deliverables while ensuring consistency of process and approaches across clinical programs within and across TAs
* Identify and implement opportunities for innovation within clinical trial operations
* Liaise closely with the Therapeutic Area Head (TAH), Development Portfolio Management (DPM), and Strategic Program Direction to ensure clinical study deliverables support clinical program goals and project execution
* Provide consolidated analysis of Key Performance Indicators (KPI) and operational metrics within the assigned TA
* Provide input into risk management strategy for clinical study teams and ensuring execution against the risk management plan
To be considered, please apply with your resume and cover letter.