About the Role
This is a hybrid position with 3 days on-site and 2 days remote work per week. The role can be based in Armonk, NY, Basking Ridge, NJ, Uxbridge, UK, or Dublin, Ireland.
The Executive Director, Therapeutic Area (TA) Operations Leader, is responsible for leading and strategically managing one or more therapeutic areas in Clinical Trial Management (CTM).
Key Responsibilities:
* Direct 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 (SOPs).
* Take a leadership role in strategy and direction for Clinical Trial Management (CTM) and Development Operations & Project Management.
* Provide sponsorship, leadership, and direction for departmental initiatives.
* Line manage staff, including recruitment, retention, professional development, and performance management.
In a typical day, 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.
* Identify and implement opportunities for innovation within clinical trial operations.
Requirements:
* Bachelor's degree, advanced degree highly desirable.
* 15+ years of clinical operations experience 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 required.
* In-depth knowledge of GCP and ICH, drug development process, and other relevant guidelines for clinical research activities.
* Experience leading global clinical research activities.
* Exceptional project management, cross-functional team leadership, and organizational skills.
Benefits
We have an inclusive and diverse culture that provides comprehensive benefits, which often include health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels.
Regeneron Values
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations.
Salary Range
$281,400.00 - $468,900.00