Director/ Head, Program Operations Leader, Non-Interventional

Tarrytown, NY, United States
Feb 21, 2019
Required Education
Bachelors Degree
Position Type
Full time
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.

The Program Operations Leader (POL) is responsible for leadership and overall strategic management of a portfolio of non-interventional clinical trials (e.g. sample collection studies, screening studies, post-approval/ authorization safety studies, observational, prospective ad retrospective studies, cohort studies, patient registry, case-control studies, retrospective chart reviews, database study using electronic health records (EHR) or 3rd party databases) within 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). The POL is a member of the Clinical Trial Management 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. The POL is responsible for line management of clinical trial management staff (e.g. Clinical Study Leads), including responsibility for staff recruitment, development, coaching, mentoring and performance management.

Job Duties:
  • Responsible for the overall success of the clinical study team(s) responsible for Non-Interventional (NI) study delivery and is the primary point of contact of leadership and oversight for the NI clinical trial management group
  • Responsible for setting strategy, goals, and objectives for the NI CTM group
  • Drives decision making and integrates all operational considerations for studies to ensure goals are attainable prior to implementation
  • Maintains an overview of clinical trial status and issues and proactively communicates progress, risks, issues or changes that may impact quality, timelines and/or budget; provide updates to stakeholders, including senior management, as requested
  • Provides operational guidance into feasibility, timeline and cost estimates during study development
  • Oversees clinical study timelines for all trials within remit
  • Provides input and operational insight into expanded study synopses
  • Reviews study plans and provision of clinical operations expertise during protocol design, feasibility, study start up and conduct phases of studies. Ensure consistency across the NI portfolio, where appropriate, and development of best practices within CTM
  • Oversees clinical study budgets: ensures review, presentation and approval of initial study budget and manages the budget and escalates concerns to TA Operations Leader, as appropriate
  • Ensures timely delivery of quality operational deliverables and accountable for ensuring consistency of process and approaches across clinical study teams
  • Acts as point of contact for study level escalation
  • Reviews key metrics and Key Performance Indicators (KPIs) across studies and within NI portfolio to track study progress
  • Provide proactive creation and implementation of risk mitigation strategies
  • Provides innovative and flexible operational solutions and options to the cross functional and development teams; assists in preparing scenarios for creative solutions to operational challenges
  • Drives the strategy and oversight for vendor selection and management
  • Manages the Clinical Research Organization (CRO) and vendor(s) as it relates to clinical program level deliverables and relationship with key CRO (functional and project) and vendor counterparts
  • Identifies, recommends and leads 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 Joint Meetings with Collaborative Partners at the study level and program level
Job Requirements:
  • Expertise in Non-Interventional, Observational studies (i.e. post approval/authorization studies, cohort studies, prospective and retrospective patient registries, case-control studies, retrospective chart reviews, database studies using electronic health records (EHR) or 3rd party databases)
  • Expertise in process evaluation and development related to non-interventional study conduct
  • Working knowledge of regulations and requirements for non-interventional studies
  • Experience with team development including strategic goals and objectives
  • Extensive experience in global clincal trial operations
  • Strong interpersonal & leadership skills
  • Ability to provide strategic direction and guidance for portfolio of studies
  • An understanding of relevant industry trends
  • Analytical skills with a data driven approach to planning, executing, and probelm solving

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.
#LI-LR1,LMR, Program Operations, Clinical Trial Program Operations, Global Development Director, non-interventional NI