Manager, Clinical Study Lead (Oncology)

Regeneron Pharmaceuticals, Inc (USA); Kentucky; On-site; USD 129,000 - 210,000; Full time

Benefits offered by this job

Annual bonuses or incentives

Equity awards

401(k) company match

Health and wellness programs

Pension/retirement benefits

On-site fitness centers

Paid time off

Family support benefits

Job summary

Regeneron Pharmaceuticals, Inc. is seeking a Manager, Clinical Study Lead to drive end-to-end delivery of clinical studies from a leading hub in the US. The role collaborates with cross-functional teams to ensure projects stay on schedule, within budget, and compliant with ICH/GCP guidelines.

Responsibilities include protocol input, site selection, investigator meetings, and oversight of CTMS/EDC/IVRS systems, with 25% travel. On-site locations include Armonk, NY; Warren, NJ; Cambridge, MA.

Qualifications

• Bachelor’s degree in a scientific or healthcare field and six+ years of relevant industry experience.
• Extensive budget management expertise within clinical study operations.
• Demonstrated vendor management experience and collaboration with CROs and vendors.

Responsibilities

• Leads cross-functional study teams and oversees delivery against timelines, deliverables, and budget.
• Provides operational input into protocol development and feasibility assessments.
• Oversees site evaluation/selection, investigator meetings, and study documentation.
• Manages study systems (CTMS, TMF) and ensures regulatory compliance and data integrity.
• Engages with outsourcing needs, vendor contracting, and management of third-party vendors.
• Leads risk assessment, patient recruitment strategies, and study close-out activities.

Skills

Budget management

Vendor management

Cross-functional leadership

Project management

Trial management systems

ICH/GCP knowledge

Microsoft Office

Global clinical trials

Education

Bachelor's degree

Tools

CTMS

TMF

IVRS/IWRS

EDC

MS Office (Project/PowerPoint/Word/Excel)

Job description

Build our future together: The Manager, Clinical Study Lead may perform the following responsibilities with moderate oversight:

Work Location: Armonk, NY, Warren, NJ, Cambridge, MA. Travel Percentage: 25% travel may be required

Responsibilities:

• Leads the cross-functional study team responsible for clinical study delivery, serving as the primary point of contact for leadership and oversight, and oversees execution against planned timelines, deliverables, and budget while raising issues (conduct, quality, timelines, budget) to the Program Operations Lead and stakeholders and implementing corrective actions.
• Provides operational input into protocol development.
• Leads feasibility assessments to select relevant regions and countries.
• Oversees or conducts site evaluation and selection.
• Leads investigator meeting preparation and execution.
• Oversees and contributes to study documentation, including case report forms, data management plan, monitoring plan, monitoring oversight plan, project-specific training plan, data review plan, statistical analysis plan, and related materials.
• Oversees set‑up and maintenance of study systems (e.g., CTMS, TMF) and ensures compliance with clinical trial registry requirements.
• Identifies outsourcing needs and leads vendor engagement, contracting, and management.
• Ensures CROs and third‑party vendors are aligned and delivering per scope of work.
• Provides input into baseline budget and timeline development and management.
• Ensures accurate budget management and scope change control for internal and external studies.
• Leads study‑level risk assessment and mitigation.
• Monitors site activation and monitoring visits and acts on deviations.
• Leads development and oversees implementation of patient recruitment and retention strategies and responds to deviations from plan.
• Monitors data entry and query resolution against agreed metrics.
• Manages study close‑out activities, including database lock, reconciliation of vendor contracts, budget, TMF, and study drug accountability.
• Contributes to clinical study report writing and review.
• Facilitates study‑level lessons learned.
• Assigns tasks to Clinical Study Management staff and supports their deliverables.
• Directly supervises CTM staff (work assignments, performance management, recruitment, professional development, coaching, mentoring, ongoing training and compliance, and study support/oversight).
• Recommends and participates in cross‑functional and departmental process improvements.
• Identifies innovative, globally informed approaches to study execution and continuous improvement of CTM SOPs.
• Assist 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.
• Support oversight of unmasked clinical monitoring.

This role requires:

• Bachelor’s degree and at least six years of relevant industry experience
• Extensive budget management expertise
• A proven ability to build productive study teams and collaborations
• Demonstrated vendor management experience
• Strong technical proficiency with trial management systems and Microsoft applications is required, including Project, PowerPoint, Word, Excel, and platforms such as IVRS/IWRS and EDC
• Experience in global clinical trial operations, including developing protocols and key study documents
• Solid knowledge of ICH/GCP and relevant regulatory guidelines and directives
• Effective project management, cross‑functional team leadership, and organizational skills
• Ability to understand and implement the operational strategic direction and guidance for respective clinical studies

Salary Range (annually) $128,600.00 - $210,000.00

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
• 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/.

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.

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.

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.