Therapeutic Area Operations Leader
This role is responsible for leadership and overall strategic management of one or more therapeutic areas in Clinical Trial Management.
The Therapeutic Area Operations Leader directs clinical operations activities and decisions, including quality, timelines, and costs related to the conduct of clinical research studies in accordance with applicable regulations, ICH/GCP regulations, and company Standard Operating Procedures within assigned TA(s).
This role takes a leadership role in strategy and direction for Clinical Trial Management and Development Operations & Project Management. It reports to the Head of CTM and interfaces with senior-level management across the TA and functions to enable efficient delivery of the assigned TA.
The role is responsible for sponsorship, leadership, and direction for departmental initiatives and line management of staff, including recruitment, retention, professional development, and performance management.
* Key Responsibilities:
* Partner with the 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)
* Contribute functional area expertise to the development of the program and clinical trial operational strategy
* Participate actively at strategy committees
* Ensure delivery of quality operational deliverables while ensuring consistency of process and approaches across clinical programs
* Identify and implement opportunities for innovation within clinical trial operations
* Liaise closely with the Therapeutic Area Head, Development Portfolio Management, and Strategic Program Direction
* Provide consolidated analysis of Key Performance Indicators (KPI) and operational metrics
Requirements:
* A Bachelor's degree, an advanced degree is highly desirable
* 15+ years' experience of clinical operations experiences in a pharmaceutical or biotech setting
* 10+ years of functional leadership, 10+ years people management, leadership, and mentoring experience
* 5+ years of leading complex, global clinical trials with outsourced CRO/FSP model(s)
* Obesity, Muscle, and Metabolism expertise is a must
* In-depth knowledge of GCP and ICH, drug development process, and other relevant guidelines for clinical research activities
* Exceptional project management, cross-functional team leadership, and organizational skills
Benefits:
* Comprehensive benefits package
* Health and wellness programs
* Fitness centers
* Equity awards
* Annual bonuses
* Paid time off for eligible employees at all levels