Regeneron · 17 hours ago
Senior Manager Clinical Study Lead (Clinical Experimental Sciences)
Armonk, NY
Full-time
Onsite
Senior Level, Lead/Staff
$150K/yr - $246K/yr
8+ years expRegeneron is a biotechnology company focused on developing medicines for serious diseases. The Senior Clinical Study Lead is responsible for the execution of clinical studies and research collaborations, overseeing all aspects from design to close-out, while ensuring compliance with regulatory standards and managing budgets and timelines.
BiopharmaBiotechnologyPharmaceutical
Responsibilities
Leads the cross-functional study team responsible for clinical study/research collaboration delivery and is the primary point of contact of leadership and oversight (as required) for the assigned study
Provides operational input into research plan and/or study protocol development
Ensures development of study specific documentation such as samples management plans and data management plans are completed on time and in accordance with the study protocol
Oversees set-up and maintenance of study systems which may include Clinical Trial Management System (CTMS), Trial Master File (TMF), study SharePoint etc
Identifies outsourcing needs of the study and leads and oversees engagement, contracting and management of required vendors, if appropriate
Provides input into baseline timeline development and management
Provides input into baseline budget development and management, facilitates internal review of the study budget for assessment of Fair Market Value
Ensures accurate budget management and scope changes for internal and external studies
Escalates issues related to study conduct, quality, timelines or budget to Program Operations Leader (POL) and other stakeholders and develops and implements appropriate actions to address issues
Oversees the execution of the clinical study against planned timelines, deliverables and budget
Oversees and ensures the CROs and Third Party Vendors are in alignment and are delivering per the scope of work
Manages and oversees study close-out activities
Ensures End of Study Summary is delivered and properly archived
Facilitates and contributes to study level lessons learned
Assigns tasks to Clinical Study Management staff and supports their deliverables
Recommends and participates in cross-functional and departmental process improvement initiatives
Responsible for identification of innovative approaches to clinical study execution including global considerations and continuous improvement departmental processes and procedures
Works with Therapeutic Focus Area groups within Basic Research/Discovery
Works closely with clinical site staff, predominantly at academic institutions
Expected to maintain higher volume and/or greater complexity studies
Expected to communicate learnings, best practices and relevant information to other study leads at all levels, ensures consistency and internal alignment across staff
May be responsible for direct supervision of CTM staff. Line management responsibilities include work assignments, performance management, staff recruitment, professional development, coaching, mentoring, ongoing training and compliance, and study support/oversight
Qualification
Required
A minimum of a Bachelor's degree
8+ years of relevant clinical experience
Benefits
Health and wellness programs (including medical, dental, vision, life, and disability insurance)
Fitness centers
401(k) company match
Family support benefits
Equity awards
Annual bonuses
Paid time off
Paid leaves (e.g., military and parental leave)
Company
Regeneron
Regeneron Pharmaceuticals specializes in the discovery, development, and commercialization of innovative medicines.
10001+ employees
H1B Sponsorship
Regeneron has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (157)
2024 (128)
2023 (128)
2022 (137)
2021 (104)
2020 (122)
Funding
Current Stage
Public CompanyTotal Funding
$15.93MKey Investors
U.S. Department of Health & Human Services
2024-07-11Post Ipo Equity· $2.03M
2023-10-18Post Ipo Equity· $5M
2016-08-22Post Ipo Equity· $8.9M
Leadership Team
Aris Baras
Senior Vice President, Regeneron Pharmaceuticals, General Manager, Regeneron Genetics Center
Bari Kowal
Senior Vice President, Head Development Operations & Portfolio Management
Recent News
2026-01-13
2026-01-09
Company data provided by crunchbase