Senior Manager, Clinical Study Lead, Inflammation & Immunology

Regeneron Pharmaceuticals, Inc.; Warren (MI); Hybrid; USD 151,000 - 246,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. seeks a Senior Clinical Study Lead to manage global, large-scale clinical trials from design to close-out.

You will lead cross-functional study teams, oversee CROs, monitor budgets, timelines, and quality, and advance processes within the Clinical Trial Management group. Ideal candidates have a Bachelor’s degree and 8+ years of global clinical operations, strong leadership, budget and vendor management, and expertise with CTMS/EDC.

Qualifications

• Bachelor’s degree with 8+ years of clinical trial experience.
• Extensive experience in global clinical trial operations.
• Line management experience and ability to build strong study teams.
• Strong budget, vendor management, and negotiation skills.
• Exceptional interpersonal, communication, and influencing skills.

Responsibilities

• Lead cross-functional study teams as the primary contact for assigned studies.
• Provide operational input into protocol development and key documents.
• Lead feasibility assessments, site evaluation, investigator meetings, and patient recruitment strategies.
• Select and oversee CROs and third-party vendors for delivery against scope of work.
• Manage study budgets and timelines with risk mitigation and escalation as needed.
• Oversee data quality, protocol deviations, and study systems to ensure audit readiness.
• Supervise Clinical Trial Management staff and drive process improvement.

Skills

Clinical trials

Global operations

Budget management

Vendor management

Leadership

Education

Bachelor’s degree

Tools

CTMS

EDC

IVRS/IWRS

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 elevate 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

Does this sound like you? 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.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. 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, and family support benefits. 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. If you have any questions, please speak with your recruiter.

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. Please speak with your recruiter and hiring manager for more information about on-site expectations for your role and location.

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.

Salary Range (annually)

$150,500.00 - $245,500.00