This is a hybrid position on-site 3 days per week and 2 days from home. This 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 Therapeutic Area (TA) Operations Leader is responsible for leadership and overall strategic management of one of more therapeutic areas in Clinical Trial Management (CTM).The Executive Director TA Operations Leader is responsible for 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 (SOP’s) within assigned TA (s).The Exec. Director TA Operations Leader is responsible to take a leadership role in strategy and direction for Clinical Trial Management (CTM) and Development Operations & Project Management.This role will report to the Head of CTM and will interface and partner with senior level management across the TA and functions to enable efficient delivery of the assigned TA.Provides sponsorship, leadership, and direction for departmental initiatives.This role is responsible for line management of 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, meets regularly 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 (e.g., feasibility, timelines, cost estimates) and participates actively at strategy committees (e.g. Development Program Review and Protocol Review)
• Ensure delivery of quality operational deliverables while ensuring consistency of process and approaches across clinical programs within and across TAs and facilitates streamlined processes across CTM TA Operations leadership
• Identify and implement opportunities for innovation within clinical trial operations and identifies trends or competitors in disease area landscape to guide operational strategy
• Liaise closely with the Therapeutic Area Head (TAH), Development Portfolio Management (DPM) and Strategic Program Direction to ensure clinical study deliverables support clinical program goals and project execution
• Provide consolidated analysis of Key Performance Indicators (KPI) and operational metrics within the assigned TA and developing/managing appropriate action plans
• Provide input into risk management strategy for clinical study teams and ensuring execution against the risk management plan.
• Oversee CRO partnership related to delivery of outsourced services, including ensuring that CTM staff provide an appropriate and documented level of oversight for site/CRO/vendor services
• Actively participate in appropriate governance meetings and acts as representative for CTM in CRO Joint Oversight Committees

• Interface with senior management to report on milestones including Clinical Operations Review meetings

To be considered, you must have:

• A Bachelors degree, an advanced degree is highly desirable.

• 15+ years’ experience of clinical operations experiences in a pharmaceutical or biotech setting with:

• 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
• 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 upon an enterprise mindset, ensuring the benefit to the whole organization.  Ability to leverage network to understand the big picture, perspectives, and expertise to maximize performance
• Ability to provide strategic direction, guidance, and timely decision-making for program teams; ability to capitalize on opportunities and manage risk
• Ability to anticipate and react to new trends in a competitive landscape and therapeutic areas to guide the organizational strategy
• Ability to 25% travel