Director, Global Clinical Trial Monitoring Strategy & Oversight

The 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 lead a team that will provide leadership and direction to the study teams for the strategy, development, performance and compliance for monitoring and site management and monitoring oversight. Responsibilities will include oversight of internal staff and vendors (Clinical Research Organizations/Functional Service Providers [CRO/FSP] and technology vendors) related to monitoring oversight. The role, along with the Associate Director for Central Monitoring, will develop the Risk Based Monitoring strategies, ensuring monitoring quality, timeliness, monitoring oversight performance, productivity and delivery. 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 monitoring oversight issue escalation.

As a site management and monitoring functional expert, the Director 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. The role is accountable for study specific monitoring strategies, including defining the monitoring and monitoring oversight strategies, developing monitoring plans and oversight monitoring plans, and providing input into budgets and cost management related to monitoring activities. This role will identify peers, engage the functional senior leadership teams and work with clinical trial management, external vendors, collaboration partners, key opinion leaders, cross functional teams, and maintain strong internal and external networks to stay abreast of industry trends.

This role is a member of the Global Clinical Trial Services (GCTS) Leadership Team, and reports to the Head of the Global GCTS group. This role leads efforts to identify high impact opportunities to advance Global Clinical Development (GCD) and Development Operations & Program Management (DO&PM) clinical trial execution model and deliver the best performance in the countries and sites where REGN conducts studies.

• Responsible and accountable for monitoring and monitoring oversight of studies in the REGN portfolio with respect to
• Risk based strategies for monitoring and oversight monitoring
• Monitoring and oversight monitoring plan authoring review and/or approval
• Execution of the defined strategies
• Ensures oversight monitoring and monitoring compliance to study plans through review of data reports, systems, and communications, including KPI/identified risks and trends using outputs from central monitoring and other functional groups, as applicable
• Ensures delivery of quality operational results while ensuring consistency of process and approaches across global monitoring
• Facilitates processes and standard methodologies within CTM and GCTS leadership
• The role will support 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 and monitoring oversight 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
• Point person for CRO/FSPs for monitoring strategies and monitoring oversight; liaises directly with CRO line management and triages with study teams and raises 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 services and compliance to monitoring plans, including items such as MV reporting, quality issues, MV frequency, burn rate, SDV completion, etc
• Liaises with Vendor Relationship Management (VRM) to ensure account communication congruency
• Functional representative at CRO governance meetings and acts as a monitoring strategies’ representative for Joint Oversight Committees (JOC)
• 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 for site monitoring and monitoring oversight activities
• Develop and maintain relationships with external clinical operations benchmarking experts
• Provides sponsorship, leadership and direction for departmental activities

• Bachelor's degree required, Advanced Degree Desirable (Master’s degree, PharmD or PhD)
• 10 + years of related experience inclusive of prior direct managerial or leadership 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 teamwork and partnerships with vendors
• Strong communicator that can translate ideas into action; outstanding written and interpersonal communication skills
• Ability to influence internally and externally
• Ability to travel up to 25%