Senior Manager, Clinical Study Lead

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

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, supporting our Inflammation & Immunology therapeutic area. The Senior Clinical Study Lead (CSL) is expected to operate with high‑degree of independence and is accountable for the global execution of assigned large and/or complex clinical trials from study design, through execution, to study close out. You will be accountable for the study timelines, study budget, and ensuring study conduct is in accordance with Regeneron Standard Operating Procedures (SOPs) and ICH/GCP. This role applies to internally sourced studies and studies out‑sourced to Clinical Research Organizations (CROs) and the balance of direct leadership versus oversight will vary accordingly.

Work Location: Armonk, NY, Warren, NJ
Work Model: Primarily on‑site with hybrid flexibility
Travel: 25% Travel may be required

Responsibilities

• Leads the cross‑functional study team responsible for clinical study delivery and is the primary point of contact of leadership and oversight (as required) for the assigned study
• Oversees and provides input to the development of study specific documentation including but not limited to: case report forms (CRF), data management plan, monitoring plan, monitoring oversight plan, project specific training plan, data review plan, statistical analysis plan, etc.
• Oversees set‑up and maintenance of study systems including but not limited to Clinical Trial Management System (CTMS), Trial Master File (TMF) etc.
• Identifies outsourcing needs of the study and leads and oversees engagement, contracting and management of required vendors
• Provides input into baseline budget development and management; Provides input into baseline timeline development and management
• Leads risk assessment and identifies risk mitigation strategies at the study level; Leads the feasibility assessment to select relevant regions and countries for the study
• Monitors progress for site activation and monitoring visits and acts on any deviations from plan
• Leads the development of and oversees implementation of patient recruitment and retention strategies and acts on any deviations from plan; Monitors data entry and query resolution and acts on any deviations from agreed metrics
• Oversees and provides input to the study drug and clinical supplies forecasting, drug accountability and drug reconciliation
• 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
• Manages and oversees study close‑out activities including but not limited to database lock, reconciliation of vendor contracts, budget, TMF, and study drug accountability
• May be assigned unmasked tasks for studies, which may include but is not limited to, assisting with masked investigational product, set up and management of unmasked trial master file, review of unmasked data in the electronic data capture system, point of contact for IVRS issues, and support oversight of unmasked clinical monitoring
• 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

Qualifications

• A minimum of 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, ability to meet deadlines, effective use of time, and prioritization
• Ability to influence and negotiate across a wide range of stakeholders
• Advanced technical proficiency in trial management systems and MS applications including (but not limited to) Project, PowerPoint, Word, Excel, IVRS/IWRS, EDC
• Extensive experience in global clinical trial operations with unique knowledge and skills to contribute to the development of protocols and key study documents
• Applies advanced expertise and implements the operational strategic direction and guidance for respective clinical studies

Compensation and Benefits

Salary Range (annually) $150,500.00 - $245,500.00

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
• family support benefits

Workplace Culture and Equal Opportunity

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.

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.

Company Overview

Regeneron is a leading biotechnology company that invents life‑transforming medicines for people with serious diseases. Founded and led for over 30 years by physician‑scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA‑approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases. Regeneron is also proud of award winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company's Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.

Additional Information

For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/.

For other locations, additional information will be provided during the recruitment process.

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.