Global Clinical Study Lead — Strategy, Delivery & Leadership

Regeneron Pharmaceuticals, Inc (USA); Armonk (NY); Hybrid; USD 151,000 - 246,000; Full time

Benefits offered by this job

Annual bonuses

Equity awards

401(k) company match

Health and wellness programs

Fitness centers

Insurance benefits

Paid time off

Family support benefits

Job summary

Regeneron Pharmaceuticals, Inc (USA) in Armonk, NY is seeking a Senior Clinical Study Lead to drive global execution of large and complex trials within Inflammation & Immunology. You will oversee study design, timelines, budgets, and ensure SOP and ICH/GCP compliance while balancing CRO oversight and direct leadership as needed.

This role requires leadership of cross‑functional teams, management of CTMS/TMF setups, vendor engagement, recruitment strategies, and study close‑out activities.

Qualifications

• A Bachelor's degree is required and a minimum of 8 years relevant clinical trial experience.
• Experience with line management as well as exceptional interpersonal and leadership skills.
• Proactive and self‑disciplined with ability to meet deadlines and prioritize.
• Advanced proficiency in trial management systems and MS applications including PowerPoint, Word, Excel, IVRS/IWRS, EDC.

Responsibilities

• Leads the cross‑functional study team responsible for clinical study delivery and is the primary point of contact of leadership and oversight for the assigned study.
• Oversees development of study documentation including CRFs, data management plan, monitoring plan, and SAP.
• Manages CTMS, TMF setup and maintenance; oversees outsourcing needs and vendor management.
• Contributes to budget and timeline development and risk assessment at the study level.
• Leads patient recruitment/retention strategies and monitors data entry and query resolution.
• Oversees drug forecasting, accountability, and reconciliation; escalates issues as needed.
• Supervises CTM staff; handles line management duties and staff development.

Skills

Leadership

Stakeholder management

Clinical trial operations

Project management

Communication

MS Office/EDC/IVRS

Education

Bachelor's degree in Life Sciences

Tools

CTMS

TMF

EDC

IVRS/IWRS

MS Office

Job description

Regeneron Pharmaceuticals, Inc (USA) in Armonk, NY is seeking a Senior Clinical Study Lead to drive global execution of large and complex trials within Inflammation & Immunology. You will oversee study design, timelines, budgets, and ensure SOP and ICH/GCP compliance while balancing CRO oversight and direct leadership as needed.

This role requires leadership of cross‑functional teams, management of CTMS/TMF setups, vendor engagement, recruitment strategies, and study close‑out activities.