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Director Program Operations Leader - Early Development

Company: Regeneron Pharmaceuticals, Inc.
Location: Basking Ridge
Posted on: June 25, 2022

Job Description:

The Director Program Operations Leader (POL) provides leadership and overall strategic management of at least one program in Clinical Trial Management (CTM). A POL is a member of the CTM extended leadership team, and as such interacts with senior level management, external vendors, collaboration partners and clinical study personnel for clinical research project and department initiatives.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)
  • Provides operational insight into feasibility, timeline and cost estimates during clinical program/study development
  • Manages clinical study timelines for the program(s)
  • Provides input into Clinical Study Concepts (CSC)
  • Oversight of clinical study budgets within a program and manages the budget through the lifecycle of the program
  • Ensures timely delivery of quality operational deliverables 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 the program(s) to ensure goals are attainable prior to implementation
  • Key point of contact for clinical program and study level escalation
  • Reviews key metrics and Key Performance Indicators (KPIs) across studies and within clinical program(s) to track study progress
  • Provides proactive creation and implementation of risk mitigation strategies
  • Provides innovative and flexible operational solutions and options to the teams; assists in preparing scenarios for creative solutions to operational challenges
  • Drives the strategy and oversight for vendor selection and management within a clinical program(s)
  • Manages the Clinical Research Organization (CRO) and vendor(s) as it relates to clinical program level deliverables
  • Identifies and recommends changes to practices and policies, including initiating and participating in strategic projects, initiatives, and continuous improvement projects within Global Development
  • Attends and represents CTM for a program(s) at review committee meetings as appropriate
  • Participates in CRO governance meetings as needed for clinical program(s)
  • Participates in Joint Meetings with Collaborative Partners at the study level and program level
  • Ensures inspection readiness throughout the clinical program lifecycle
  • Responsible for CTM resource forecasting and resource allocation for clinical studies across one or more clinical programs
  • Responsible for direct supervision of CTM staff e.g.performance management, staff recruitment, professional development, coaching, mentoring, ongoing training and compliance, etcThis role might be for you if:You have strong interpersonal & leadership skillsYou can provide strategic direction and guidance for clinical programsYou have analytical skills with a data driven approach to planning, executing, and problem solvingYou are proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritizationTo be considered for this opportunity:You must possess a Bachelors' degree with a minimum of 12 years of relevant industry experience, including 8 years within the function. Advanced degrees may be considered in lieu of relevant experience.We need extensive experience in global clinical trial operations. We must have demonstrated vendor management & budget management experience. In addition, we also need proven line management experience. Up to 25% travel may be required.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 amazing 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 maternity 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.

Keywords: Regeneron Pharmaceuticals, Inc., Newark , Director Program Operations Leader - Early Development, Executive , Basking Ridge, New Jersey

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