Job Summary
This role is responsible for strategic leadership and operational management of clinical trial activities. The successful candidate will oversee the planning, execution, and delivery of clinical research studies within assigned therapeutic areas.
The Executive Director TA Operations Leader will provide direction and guidance to cross-functional teams, ensuring timely and quality delivery of clinical trials while adhering to regulatory requirements and company standards.
Key Responsibilities:
* Partners with Therapeutic Area Head and Global Program Heads to review progress and project status
* Responsible for the successful operational delivery of all studies within the Clinical Development Plan (CDP)
* Contributes functional area expertise to program and clinical trial operational strategy
* Liaises closely with Development Portfolio Management and Strategic Program Direction to ensure clinical study deliverables support clinical program goals
* Provides consolidated analysis of Key Performance Indicators (KPI) and operational metrics within the assigned TA
* Oversees CRO partnership related to delivery of outsourced services
Requirements:
* Bachelor's degree or advanced degree highly desirable
* 15+ years' experience in clinical operations in a pharmaceutical or biotech setting
* 10+ years of functional leadership and 10+ years people management experience
* 5+ years leading complex, global clinical trials with outsourced CRO/FSP model
* In-depth knowledge of GCP and ICH guidelines for clinical research activities
Benefits:
* Comprehensive benefits package including health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees
About Us:
* We have an inclusive and diverse culture that values diversity and promotes equal opportunities
* We are committed to providing a safe and healthy work environment