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Executive Director
1 month ago
This is a hybrid position that requires working on-site 3 days per week and 2 days from home. The role can be based in Armonk, NY, Basking Ridge, NJ, Uxbridge, UK, or Dublin, Ireland. A fully remote role is not possible for this position.
The Executive Director TA Operations Leader is responsible for leading the strategic management of one or more therapeutic areas in Clinical Trial Management (CTM). This role involves directing 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) within assigned TAs.
Key Responsibilities:- Partner with the Therapeutic Area Head and Global Program Heads to review TA progress and project status.
- Ensure the successful operational delivery of all studies in the TA within the Clinical Development Plan (CDP).
- Contribute functional area expertise to the development of program and clinical trial operational strategy.
- Deliver high-quality operational deliverables while ensuring consistency of process and approaches across clinical programs within and across TAs.
- Identify opportunities for innovation within clinical trial operations and provide analysis of Key Performance Indicators (KPI) and operational metrics.
To succeed in this role, you will need:
- A Bachelor's degree; an advanced degree is highly desirable.
- 15+ years of clinical operations experience in a pharmaceutical or biotech setting, with:
- 10+ years of functional leadership, people management, leadership, and mentoring experience.
- 5+ years of leading complex, global clinical trials with outsourced CRO/FSP models.
- 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.
- Obesity, Muscle, and Metabolism expertise is a must.
- Ability to make decisions, set priorities, and share resources based upon an enterprise mindset.
- Ability to leverage network to understand the big picture, perspectives, and expertise to maximize performance.
- Ability to travel 25% of the time.
Regeneron is an equal opportunity employer and welcomes applications from diverse candidates. We offer a comprehensive benefits package and a dynamic work environment.
