Executive Director, Therapeutic Area Operations Leader - Hematology / Oncology

The Executive Director Therapeutic Area (TA) Operations Leader has leadership and overall strategic management of one of more therapeutic areas in Clinical Trial Management (CTM). The Executive Director TA Operations Leader advises 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). This role will report to the Heads of CTM and will interface and partner with senior level management across the TA and functions to enable efficient delivery of the assigned TA. This role has line management of staff including recruitment, retention, professional development, and performance management.

A typical day includes:

• Partnering 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)
• Contributes 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)
• Ensures delivery of quality operational results while ensuring consistency of process and approaches across clinical programs within and across TAs and facilitates streamlined processes across CTM TA Operations leadership
• Identifies and implements opportunities for innovation within clinical trial operations and identifies trends or competitors in disease area landscape to guide operational strategy
• Collaborates closely with the Therapeutic Area Head (TAH), Development Portfolio Management (DPM) and Strategic Program Direction to ensure clinical study results support clinical program goals and project execution

This job may be for you if you are:

• Responsible for providing input into risk management strategy for clinical study teams and ensuring execution against the risk management plan.
• Lead all aspects of 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 participates in appropriate governance meetings and acts as representative for CTM in CRO Joint Oversight Committees
• Collaborates with senior management to report on achievements including Clinical Operations Review meetings
• Responsible for CTM resource forecasting and resource allocation for the clinical studies across assigned TA (s) and overall for CTM.
• Provides leadership and coaching to build a successful team, ensuring recruitment, performance management and development of team/staff line management.

To be considered you should possess a Bachelor's degree and:

• 15+ years’ experience of clinical operations experiences in a pharmaceutical or biotech setting, 10+ years of functional leadership, people management, leadership and mentoring experience and at least 5+ years of leading sophisticated, global clinical trials with an outsourced CRO/FSP model(s).
• Experience within Oncology is required. Hem-onc experience is strongly preferred.
• In depth knowledge of GCP and ICH, drug development process, and 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 approach, ensuring the benefit to the whole organization.
• Ability to provide strategic direction, guidance, and timely decision-making for program teams; ability to capitalize on opportunities and handle risk
• Strong financial competence in regards to program & study budget management
• Ability to generate and encourage trust of others, lead with integrity.

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Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and 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. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.

Salary Range (annually)

$269,000.00 - $448,300.00