Director Program Operations Leader

The Director Program Operations Leader (POL) is responsible for leadership and overall strategic management of one or more sophisticated 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 Dir 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.

• 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 team members as requested
• Provides operational insight into feasibility, timeline and cost estimates during clinical program/study development
• Leads all aspects of clinical study timelines within a clinical program(s)
• Is responsible for clinical study budgets within a program: ensures review, presentation and approval of initial study budget and leads the budget through the lifecycle of the program by communicating 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).
• Acts as point of contact for clinical program and study level issue
• Reviews key metrics and Key Performance Indicators (KPIs) across studies and within clinical program(s) to supervise study progress
• Provides creation and implementation of risk mitigation strategies
• Provides operational solutions and options to the cross functional and development teams; assists in preparing scenarios for creative solutions to operational challenges
• Owns the Clinical Research Organization (CRO) and vendor(s) as it relates to clinical program level results and relationship with key CRO (functional and project) and vendor counterparts

• Minimum of a Bachelor’s degree
• Advanced degrees may be considered in lieu of proven experience
• Minimum of 12 years relevant proven experience, 8 years within the function

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 extraordinary benefits including health and wellness programs, fitness centers and stock for 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.