Job Title: Executive Director Therapeutic Area Operations Leader
About the Role:
This is a hybrid position requiring on-site work 3 days a week and remote work 2 days a week.
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.
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 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.
Responsible for line management of staff, including recruitment, retention, professional development, and performance management.
Requirements:
Bachelor's degree; an advanced degree is highly desirable.
15+ years of clinical operations experience in a pharmaceutical or biotech setting, including 10+ years of functional leadership, 10+ years of people management, leadership, and mentoring experience, 5+ years of leading complex, global clinical trials with outsourced CRO/FSP models.
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.
Experience leading global clinical research activities.
Exceptional project management, cross-functional team leadership, and organizational skills.
Ability to make decisions, set priorities, and share resources based on an enterprise mindset.
Ability to leverage network to understand the big picture, perspectives, and expertise to maximize performance.