This is a hybrid position 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. However, a fully remote role is not possible for this position.
Job Description:
The Executive Director Therapeutic Area (TA) Operations Leader is responsible for leadership and overall strategic management of one or more therapeutic areas in Clinical Trial Management (CTM).
Key responsibilities include 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.
The Executive Director TA Operations Leader will also 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.
Responsibilities include providing sponsorship, leadership, and direction for departmental initiatives, as well as 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, meeting regularly 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, including feasibility, timelines, cost estimates, and participates actively at strategy committees.
* Evaluate and ensure delivery of quality operational deliverables while ensuring consistency of process and approaches across clinical programs within and across TAs, facilitating streamlined processes across CTM TA Operations leadership.
* Identify and implement opportunities for innovation within clinical trial operations and identify trends or competitors in disease area landscapes 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 (KPIs) and operational metrics within the assigned TA, 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 delivery of outsourced services, ensuring that CTM staff provide an appropriate and documented level of oversight for site/CRO/vendor services.
* Actively participate in governance meetings and act as representative for CTM in CRO Joint Oversight Committees.
To be considered, you must have:
* A Bachelor's degree; an advanced degree is highly desirable.
* 15+ years' experience in clinical operations in a pharmaceutical or biotech setting with:
o 10+ years' of functional leadership, 10+ years' people management, leadership, and mentoring experience.
o 5+ years' 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 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 travel 25%.
This role offers a comprehensive compensation package, including health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, 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.
The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.