Dir Program Operations Leader

Job Description

The Director Program Operations Leader (POL) is responsible for leadership and overall strategic management of one or more complex programs in Clinical Trial Management (CTM). This individual is responsible for clinical operations activities and decisions including quality, timelines and budgets related to the conduct of clinical research studies in accordance with applicable regulations, ICH/GCP regulations and company Standard Operating Procedures (SOPs) within assigned program(s). The Director POL is a member of the Clinical Trial Management extended leadership team, and as such interacts with senior level management, external vendors, teamwork partners and clinical study personnel for clinical research project and department initiatives. The Director POL is responsible for line management of clinical trial management staff, including responsibility for staff recruitment, development, coaching, mentoring, and performance management.

In this role, a typical day might include the following:

• Responsible for the overall success of the clinical study team(s) within a program(s)

• Maintains an overview of clinical program(s) status and issues and proactively communicates progress, risks, issues or changes that may impact quality, timelines and/or budget; provide clinical program level updates to customers as requested

• Provides operational insight into feasibility, timeline and cost estimates during clinical program/study development

• Review of plans and provision of clinical operations expertise during protocol design, feasibility, study start up and conduct phases of studies. Ensure consistency within the program and development of standard methodologies within CTM

• Leads all aspects of clinical study budgets within a program: ensures review, presentation and approval of initial study budget and handles the budget through the lifecycle of the program by presenting changes to TA Operations Leader, as appropriate

• Ensures timely delivery of quality operational results and accountable for ensuring consistency of process and approaches across clinical study teams within the clinical program(s).

• Drives decision making and integrates all operational considerations for studies within a clinical program(s) to ensure goals are attainable prior to implementation

This role might be for you if:

• Responsible for direct supervision of CTM staff. Line management responsibilities include: work assignments, performance management, staff recruitment, professional development, coaching, mentoring, ongoing training and compliance, and study support/oversight.

• Bachelor’s degree

• Advanced degrees may be considered in lieu of relevant experience

• Minimum of 12 years relevant industry experience, 8 years within the function

• Oncology experience is required, hematology is strongly preferred

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)

$193,200.00 - $322,000.00