Senior Manager – Clinical Trial Liaison

Job not on LinkedIn

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $134.4k - $219.2k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

🦅 H1B Visa Sponsor

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Regeneron

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1988

🏥 Healthcare

🏭 Manufacturing

🧬 Biotechnology

💰 Post-IPO Equity on 2023-10

Healthcare • Manufacturing • Biotechnology

Regeneron is a biotechnology company dedicated to turning scientific discoveries into life-changing medicines. The company focuses on a range of serious diseases including allergic, cardiovascular, and metabolic diseases, neuroscience, oncology, hematology, ophthalmology, and rare diseases. It achieves this by integrating biology and technology to develop cutting-edge biologics and genetic medicines. Regeneron is committed to health equity, environmental sustainability, and supporting future STEM talent through initiatives like the Regeneron Science Talent Search. By maintaining high ethical standards and corporate responsibility, Regeneron aims to push the boundaries of science for better healthcare solutions.

📋 Description

• Manage day-to-day operational oversight for delivery of defined therapeutic areas/projects within the Americas region for the Clinical Trial Liaison team • Manage and oversee the performance of field-based CTLs and CTL staff provided by third-party FSP vendors • Implement and execute portfolio-wide operational strategy for assigned therapeutic areas • Build relationships with investigators and investigator site staff • Identify potential new investigators to support optimal placement of clinical trials • Provide input in cross-functional forums on study, program, and operational strategies • Conduct line management and performance oversight of assigned CTLs, including goals, deliverables, metrics, reviews, and development planning • Support resource planning and capacity recommendations • Monitor FSP CTL performance against service-level agreements and escalate concerns • Ensure CTL execution of study deliverables, including feasibility, site identification and selection, patient recruitment, and retention • Identify process improvements and advocate for the CTL team • Maintain relationships with internal stakeholders and the external investigator community • Participate in remote and onsite co-visits with CTLs at investigator sites for coaching, oversight, and clinical trial execution • Act as the first escalation point for internal study teams, sites, and CRO partners • Support CTL attendance at investigator meetings • Produce monthly performance summaries for the Regional Head • Work with Medical Affairs/Field Medical teams to support CTLs in local meetings • Support CTLs in regulatory GCP inspections and/or audits as sponsor representative • May work up to 15% as a CTL on studies and with sites • Support onboarding, identify training needs, and ensure consistent role, study, systems, and compliance training across CTLs

🎯 Requirements

• Bachelor's degree as a minimum • Master's/Ph.D./PharmD. degree preferred • Minimum 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 • 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 communication of technical and scientific information • Excellent interpersonal skills and collaborative and independent working style • Ability to build effective relationships with principal investigators and site staff • Strong organizational skills with effective time use and prioritization • Cross-cultural awareness • Fluent in Business English • Strong operational Clinical Trial Liaison experience with consistent and excellent performance metrics • Coaching and mentoring experience

🏖️ Benefits

• 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 benefits • Paid time off • Family support benefits • Reasonable accommodation during the recruitment process where required • Inclusive workplace culture