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

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!

Regeneron is 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. 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.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

Salary Range (annually)

$281,400.00 - $468,900.00

Executive Director

Therapeutic Area Operations Leader-Obesity, Muscle, Metabolism

Regeneron Pharmaceuticals

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