Senior Manager, Clinical Study Lead, Inflammation & Immunology

Regeneron Pharmaceuticals, Inc; Cambourne; Hybrid; GBP 112,000 - 146,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. is seeking a Senior Clinical Study Lead to join the Clinical Trial Management team. You will globally manage large, complex trials from design to closeout, leading cross-functional study teams, overseeing CROs, and ensuring timeliness, budget adherence, and compliance with ICH/GCP and Regeneron SOPs.

Location options include on-site with hybrid flexibility; travel up to 25%. You will supervise staff, drive process improvements, and contribute to clinical study

Qualifications

• Bachelor's degree and 8+ years of relevant clinical trial experience.
• Extensive global clinical trial operations experience with ICH/GCP knowledge.
• Line management experience and ability to build, lead, and develop productive study teams.
• Strong budget management, vendor management, and negotiation skills.

Responsibilities

• Lead cross-functional study teams with accountability for timelines, budget, and quality.
• Provide operational input into protocol development and key study documents (data management, monitoring,.SAP).
• Lead feasibility assessments, site evaluation and selection, investigator meetings, and patient recruitment strategies.
• Select, contract, and oversee CROs and vendors to ensure delivery against scope of work.
• Manage study budgets and timelines, identify risks, and escalate issues with mitigation plans.
• Oversee data quality, protocol deviations, and study systems (CTMS, TMF) to ensure audit readiness.
• Supervise and develop Clinical Trial Management staff while driving process improvement.

Skills

Cross-functional leadership

Budget management

Vendor management

Communication skills

Team leadership

Education

Bachelor's degree

Tools

CTMS

EDC

IVRS/IWRS

MS Office

Job description

Build our future together:

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Senior Clinical Study Lead to join our Clinical Trial Management team, accountable for the global execution of large and complex clinical trials from study design through close out. In this role, you will lead cross-functional study teams and oversee CROs and vendors, ensuring studies are delivered on time, on budget, and in accordance with ICH/GCP and Regeneron SOPs. You will also supervise Clinical Trial Management staff and drive process improvement initiatives. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

When & where:

• Location: Tarrytown, NY, Warren, NJ, Cambridge, MA
• Work model/flexibility: Primarily on-site with hybrid flexibility
• Travel percentage: Up to 25%

Discover your role:

• Lead the cross-functional study team as the primary point of contact for assigned studies, with high independence and accountability for timelines, budget, and quality
• Provide operational input into protocol development and key study documents, including data management, monitoring, and statistical analysis plans
• Lead feasibility assessments, site evaluation and selection, investigator meetings, and patient recruitment and retention strategies
• Select, contract, and oversee CROs and third-party vendors to ensure delivery against the scope of work
• Manage study budgets and timelines, identify risks, and escalate issues with clear mitigation plans
• Oversee data quality, protocol deviations, and study systems such as CTMS and TMF to keep studies audit and inspection ready
• Manage study close-out activities and contribute to clinical study reports and lessons learned
• Supervise, coach, and develop Clinical Trial Management staff while driving innovation and process improvement across the department

This role requires:

• Bachelor's degree and 8+ years of relevant clinical trial experience
• Extensive experience in global clinical trial operations, with knowledge of ICH/GCP and regulatory guidelines
• Line management experience and the ability to build, lead, and develop productive study teams
• Strong budget management, vendor management, and negotiation skills
• Exceptional interpersonal, communication, and influencing skills across a wide range of stakeholders
• Preferred: Advanced proficiency in trial management systems (CTMS, EDC, IVRS/IWRS) and MS applications
• Preferred: Awareness of relevant industry trends and experience driving process improvement