Senior Manager, Clinical Study Inspection Readiness

BioSpace; Armonk (NY); On-site; USD 151,000 - 246,000; Full time

Job summary

Regeneron is seeking a Senior Manager, Clinical Study Inspection Readiness to lead GCP inspection readiness across complex portfolios. You will be the primary contact for inspection activities, coordinating with Program Operations Leaders, Clinical Study Leads, CROs, and Inspection Management.

The role requires 8+ years of clinical experience, strong project management, and collaboration across internal teams.

Qualifications

• BS/BA degree in a life sciences field required.
• 8+ years of relevant clinical experience.
• Strong project management instincts under inspection timelines.
• Experience with CROs and cross-functional clinical study teams is preferred.

Responsibilities

• Lead GCP inspection readiness programs across multi-program portfolios.
• Own inspection process end-to-end: mock, dry run, actual inspections.

Skills

GCP inspection

Project management

QA compliance

Communication

Education

BS/BA in life sciences

Tools

AI productivity tools

SOPs/Business Practice Tools

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 Manager, Clinical Study Inspection Readiness to join our Clinical Trial Management function, supporting inspection readiness across one or more assigned clinical programs. In this role, you will lead GCP inspection readiness strategy and serve as the primary point of contact for all inspection-related activities, while collaborating closely with Program Operations Leaders, Clinical Study Leads, CRO partners, and Inspection Management.

When & Where

• Location: Armonk, NY, Warren, NJ


• Travel percentage: Up to 25%

Discover Your Role

• Lead GCP inspection readiness programs across complex, multi-program portfolios spanning internal teams, CRO partners, and Inspection Management


• Own the inspection process end-to-end mock, dry run, and actual managing follow-up requests from inspectors and inspection management teams


• Partner with Clinical Study Teams and functional areas to prepare Q&A responses and drive action items to closure


• Guide CTM staff on compliance with SOPs, Business Practice Tools, and Work Instructions throughout the study lifecycle


• Track inspection readiness meetings, action items, storyboards, and presentation requests with internal and CRO stakeholders through resolution


• Manage the full inspection action item lifecycle from pre-inspection readiness through post-inspection remediation, timelines, and closure ensuring a complete audit trail


• Champion use of AI-powered tools to accelerate high-quality deliverables, from executive summaries and storyboards to CAPA narratives and TMF gap analyses


• Coach, develop, and set goals and accountabilities for direct reports, reviewing performance against quality and timeliness standards

This Role Requires

• BS/BA degree and 8+ years of relevant clinical experience


• Strong project management instincts, especially under the pressure of live inspection timelines


• Preferred: hands‑on clinical inspection experience (mock, dry run, or actual regulatory inspections)


• Preferred: experience partnering with CROs and cross‑functional clinical study teams


• Preferred: familiarity with AI-powered productivity tools (e.g., Claude, Microsoft Copilot) in a documentation or compliance context


• Proactive risk thinking identifying Sites of Interest and documentation gaps before they become findings


• Clear, confident communication across internal teams, CRO partners, and inspectors


• Comfort leading and coaching others while staying hands‑on with the details

Salary Range (annually)

$150,500.00 - $245,500.00

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.

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 onsite. Please speak with your recruiter and hiring manager for more information about onsite 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.