Senior Manager Clinical Trial Liaison

Regeneron Pharmaceuticals
•$134,400 - $219,200•Remote

About The Position

The Senior Manager, Clinical Trial Liaison Manager (CTL-M), provides day-to-day operational oversight for delivery of defined therapeutic areas and projects within the Americas region for the Clinical Trial Liaison team. Working within Development Operations and Portfolio Management, the role collaborates with peer CTL Managers, Country Cluster Managers, the Regional Head of CTLs, and cross-functional stakeholders to implement portfolio-wide operational strategy. The Senior Manager manages and oversees the performance of field-based CTLs and the operational delivery of CTL staff provisioned through third-party FSP vendors. As the field-based point of contact for assigned therapeutic areas or projects, the Senior Manager and team build relationships with investigators and site staff, identify potential investigators, and support optimal placement of clinical trials while meeting cost, quality, and speed targets. The position reports to the Regional Head CTL (Americas), is remote in the United States, and requires 30–40% travel.

Requirements

  • Bachelor’s degree at minimum.
  • At least 8 years of relevant industry and/or CRO experience in clinical trial operations.
  • At least 3 years in a people management role with direct line-management accountability.
  • Demonstrated line and performance management experience, including formal performance reviews and development planning.
  • Extensive experience in global clinical trial operations and a track record of managing and developing field-based teams.
  • Extensive scientific knowledge and understanding of clinical development, including ICH GCP and regional regulatory requirements.
  • Excellent communication skills for technical and scientific information.
  • Excellent interpersonal skills and the ability to work collaboratively and independently.
  • Ability to build effective relationships with the external scientific community, including principal investigators and site staff.
  • Strong organizational skills, including effective time management and prioritization.
  • Cross-cultural awareness and fluency in Business English.
  • Strong operational Clinical Trial Liaison experience with consistent and excellent performance metrics.
  • Coaching and mentoring skills.

Nice To Haves

  • Master’s, Ph.D., or PharmD degree.

Responsibilities

  • Provide input in cross-functional forums to align study, program, and operational strategies for field-based CTL delivery.
  • Manage assigned CTLs’ day-to-day work and performance, including goals, deliverables, metrics, reviews, and development planning; partner with other CTL Managers and Country Cluster Managers to support a high-performing team.
  • Escalate complex or out-of-policy performance matters to the Regional Head.
  • Support the Regional Head in overseeing CTL activities and workload assignments, and provide input into resource planning and capacity recommendations.
  • Participate in vendor engagement meetings and monitor FSP CTL performance against service-level agreements, escalating concerns to the Regional Head.
  • Ensure effective CTL execution of study deliverables, including early outreach and feasibility, site identification and selection, and patient recruitment and retention.
  • Identify potential process improvements, make recommendations to the Regional Head, and advocate for the CTL role and team with internal and external stakeholders.
  • Build and maintain relationships with internal stakeholders and the external investigator community relevant to the therapeutic area.
  • Conduct periodic remote and onsite co-visits with assigned CTLs at investigator sites to coach and oversee CTLs, support trial execution, and report to study teams on feasibility, start-up, enrollment, and escalated site issues.
  • Serve as the CTL team’s first point of escalation for internal study teams, sites, and CRO partners; resolve operational and site-level matters within established authority and escalate complex or systemic issues.
  • Support CTL attendance at investigator meetings for assigned studies.
  • Prepare monthly performance summaries for the Regional Head covering CTL activity metrics, standards, issues, and escalations.
  • Work with Medical Affairs or Field Medical teams, as applicable, to support CTLs at local meetings such as kick-off meetings.
  • Support CTLs during regulatory GCP inspections and/or audits as a sponsor representative when necessary.
  • May work up to 15% as a CTL on assigned studies and sites, performing activities according to required and agreed CTL metrics.
  • Support onboarding as assigned by the Regional Head, identify training needs, and ensure consistent role, study, systems, and compliance training across CTLs.

Benefits

  • Competitive and comprehensive total rewards package, which may include annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, medical, dental, vision, life and disability insurance, paid time off, and family support benefits, depending on country and role.
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