Senior Manager Clinical Trial Liaison

Regeneron Pharmaceuticals, Inc.; United States; À distance; USD 134 000 - 219 000; Plein temps

Résumé du poste

Regeneron Pharmaceuticals, Inc. is seeking a Senior Manager, Clinical Trial Liaison (CTL) Manager to oversee day-to-day operational delivery of CTL activities in the Americas.

You will lead field-based CTLs, manage performance, and coordinate with cross-functional stakeholders to implement strategy and ensure timely, quality study execution. Ideal candidates bring extensive global CTL operations experience, strong leadership and communication skills, and a track record of building

Qualifications

• Bachelor's degree minimum; advanced degrees preferred for scientific/clinical role.
• 8+ years of industry and/or CRO experience in clinical trial operations; at least 3 years in people management.
• Extensive global clinical trial operations experience with track record of managing field-based teams.

Responsabilités

• Provide day-to-day line management and performance oversight of CTLs; manage goals and metrics.
• Oversee CTL activities and workload planning; advise on resource capacity.
• Monitor vendor performance and engage with FSP CTLs to meet SLAs.
• Ensure CTL execution of key deliverables: feasibility, site identification, recruitment.
• Identify process improvements; advocate CTL role with stakeholders.
• Build relationships with investigators and external scientific community.

Connaissances

Leadership

Communication

Cross-functional collaboration

Formation

Bachelor's degree

Advanced degree preferred

Description du poste

Location: United States

Build our future together:

The Senior Manager, Clinical Trial Liaison Manager (CTL-M), manages the day-to-day operational oversight for delivery of defined therapeutic areas/projects within the Americas region for the Clinical Trial Liaison (CTL) team. Working within Development Operations and Portfolio Management (DO&PM), the incumbent engages closely with peer Clinical Trial Liaison Managers, Country Cluster Managers, the Regional Head of CTLs, and cross-functional stakeholders to implement and execute portfolio-wide operational strategy for their therapeutic areas.

The Senior Manager is responsible for the management and performance of field-based CTLs within their team. The role reports to the relevant Regional Head CTL (Americas) and is also responsible for the operational oversight of CTL staff provisioned via any third-party FSP vendor.

As the field-based point of contact for their therapeutic areas/project, the Senior Manager and their CTL team are responsible for building strong relationships with investigators and investigator site staff, identifying potential new investigators to support optimal placement of Regeneron clinical trials, and delivering against cost, quality and speed targets.

When & where:

• Location: Remote - United States
• Travel percentage: 30-40% of time

Discover your role:

Provides input in cross-functional forums to support alignment on study, program, and operational strategies for field-based CTL delivery

• Provides day-to-day line management and performance oversight of assigned CTLs, including management of team and individual goals and deliverables, monitoring of agreed CTL metrics, metric reviews, development planning, and partnership with other CTL Managers/Country Cluster Managers to build a high-performing team that consistently delivers quality outcomes in alignment with established standards, timelines, and regional processes; escalates complex or out-of-policy performance matters to the Regional Head
• Supports the Regional Head in overseeing CTL activities and workload assignments; provides input into resource planning and capacity recommendations
• Partners closely with the Regional Head, participates in vendor engagement meetings, and monitors FSP CTL performance against agreed service-level agreements, escalating performance concerns to the Regional Head
• Ensures effective CTL execution of key study deliverables, including early outreach/study feasibility, site identification and selection, and patient recruitment and retention.
• Proactively identifies areas of potential process improvement and makes recommendations to the Regional Head; advocates for the CTL role and team with internal and external stakeholders
• Builds and maintains effective relationships with key internal stakeholders and the external investigator community relevant to the therapeutic area
• Participates in periodic remote and onsite co-visits with assigned CTLs at investigator sites to provide coaching and oversight, support clinical trial execution, and report to study teams on feasibility, start-up activities, enrollment, and escalated site issues as required
• Acts as the first point of escalation for the CTL team for internal study teams, sites, and CRO partners; resolves operational and site-level matters within established authority, escalating complex or systemic issues to the Regional Head
• Supports CTL attendance at Investigator meetings for studies within their assigned therapeutic areas/projects
• Produces monthly performance summaries for the Regional Head covering CTL activity metrics, standards, issues, and escalations
• Works with Medical Affairs/Field Medical teams as applicable, to support CTLs in local meetings (e.g. kick-off meetings)
• Supports CTLs in regulatory GCP inspections and/or audits as sponsor representative as necessary
• May work up to 15% as a CTL on studies and with sites as assigned by the RH performing all activities according to the required and agreed metrics for CTL activities
• Supports onboarding activities as assigned by the Regional Head, identifies training needs, and ensures consistent role, study, systems, and compliance training across CTLs

This role requires:

• Bachelor's degree as a minimum; Master's/Ph.D./PharmD. degree preferred for this scientific and clinical role. Minimum 8 years of relevant industry and/or CRO experience in clinical trial operations, with 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 required, with a track record of managing and developing field-based teams
• Extensive scientific knowledge and understanding of the clinical development process (including ICH GCP and regional regulatory requirements)
• Excellent communicator of technical and scientific information
• Excellent interpersonal skills and demonstrated collaborative as well as independent working style
• Ability to build effective relationships with the external scientific community, including principal investigators and site staff
• Strong organizational skills with effective use of time and prioritization
• Cross cultural awareness and fluent in Business English
• Strong operational Clinical Trial Liaison experience with consistent and excellent performance metrics
• Coaching and mentoring
  

We are committed to building a workplace with an inclusive culture. 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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit . For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually)

$134,400.00 - $219,200.00