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Regeneron Pharmaceuticals Assoc Director, Global Clinical Trial Monitoring Strategy & Oversight in Basking Ridge, New Jersey

The Associate Director Global Monitoring Strategy & Oversight will develop team strategies for site management and monitoring oversight, and, management of monitoring oversight activities for a defined portfolio. This role will provide leadership and direction to the assigned study teams for the strategy, development, performance and compliance for monitoring and monitoring oversight. Responsibilities will include oversight of vendors (Clinical Research Organizations/Functional Service Providers [CRO/FSP] and technology vendors) for assigned portfolio. The role will work closely with the Director, Global Monitoring Strategy & Oversight and the Associate Director for Central Monitoring in developing the Risk Based Monitoring strategies, ensuring quality, timeliness, oversight performance, productivity and delivery. The Associate Director will also implement the strategy and operations of monitoring oversight activities. The role is the primary point of contact for oversight monitoring CRO/FSP functional/study leadership, line management and is the pathway for monitoring strategy and oversight issue escalation in the assigned portfolio.

As a site management and monitoring functional expert, the Associate Director, along with the Director, Global Monitoring Strategy & Oversight, will take a leadership role in strategy and direction for monitoring oversight and will work closely with Program/study teams to build a fit for purpose monitoring strategy based on study design and operational requirements. For the assigned portfolio, this role is accountable for study specific strategies, including defining the monitoring and oversight strategies, developing monitoring plans, and providing input into budgets and cost management related to monitoring activities.

Job responsibilities:

  • Responsible and accountable for monitoring and monitoring oversight of studies in the assigned REGN portfolio with respect to risk-based strategies

  • Monitoring and oversight monitoring plan authoring review and/or approval and execution of the defined strategies, identification and implementation of changes, as required

  • Ensures oversight monitoring compliance to study plans through review of data reports, systems, and communications, including KPI/identified risks and trends leveraging outputs from central monitoring and other functional groups, as applicable

  • Ensures delivery of quality operational deliverables while ensuring consistency of process and approaches across global monitoring

  • Facilitates streamlined processes and best practices within CTM and GCTS leadership

  • The role will support the POL/CSL, during budget preparation and budget review meetings, ensuring the site management and monitoring strategies are appropriately accounted for within the study team budget

  • Working with Global Trial Optimization and the POL/CSL, monitors budgetary impact during country selection and budget development, where applicable

  • Provides strategic and operational input on risk-based study planning and ensures monitoring execution against the risk management plan

  • Responsible for analysis of Key Performance Indicators (KPI) and operational metrics and developing, implementing and leading appropriate action plans

  • Within the assigned portfolio, act as functional Point of Contact for CRO/FSPs for monitoring strategies and monitoring oversight; liaises directly with CRO line management and triages with study teams and escalates monitoring performance areas of concern to the appropriate governance

  • Assists study teams with study specific monitoring strategies (defining critical data, visit schedule, etc), and approves plans for all studies

  • Oversee quality of monitoring services and compliance to monitoring plans, including items such as MV reporting, quality issues, MV frequency, burn rate, SDV completion, etc

  • Partners with Global Strategic Sourcing & Procurement to review CRO/vendor specifications, bid information and interrogate CRO/vendor activities, units and costs to derive an appropriate study operating budget

Job requirements:

  • Bachelor's degree required, Advanced Degree Desirable (Master’s degree, PharmD or PhD)

  • 5-7 years of related experience

  • Complete knowledge of the drug development process and specific knowledge of clinical trial, clinical monitoring and site management process, and associated industry regulations

  • Experience working with/establishing global clinical site management and monitoring and deep knowledge of operating space

  • Someone who will lead by example to foster an entrepreneurial culture of ingenuity, innovation and thought leadership; proven change management skills

  • Track record of building collaboration and partnerships with vendors

  • Strong communicator that can translate ideas into action; exemplary written and interpersonal communication skills

  • Ability to influence internally and externally

  • Ability to travel up to 25%