Senior Manager, Clinical Study Inspection Readiness

Regeneron Pharmaceuticals, Inc (USA); Armonk (NY); On-site; USD 150,500 - 245,500; Full time

Benefits offered by this job

Annual bonuses

401(k) company match

Health and wellness programs

Job summary

Regeneron Pharmaceuticals, Inc (USA) is seeking a Senior Manager, Clinical Study Inspection Readiness to oversee GCP inspection activities for clinical programs. This role involves collaborating with program leaders and ensuring compliance with ICH/GCP guidelines.

The ideal candidate has over 8 years of clinical experience, strong project management skills, and proficiency in AI tools. The position offers a competitive salary and comprehensive benefits.

Qualifications

• 8+ years of relevant clinical experience.
• Clinical inspection experience strongly preferred.
• Knowledge of ICH guidelines and clinical trial documentation.
• Experience managing complex clinical portfolios.

Responsibilities

• Lead mock, dry‑run, and actual inspections.
• Guide and support Clinical Study Teams during inspections.
• Ensure Trial Master File (TMF) documentation is maintained.
• Manage inspection action items throughout their lifecycle.
• Utilize AI applications to enhance documentation.

Skills

Good Clinical Practice (GCP)

Project management

Communication skills

Stakeholder management

AI tools proficiency

Education

BS/BA degree

Job description

Senior Manager, Clinical Study Inspection Readiness

Lead all Good Clinical Practice (GCP) inspection readiness activities for one or more assigned clinical programs within Clinical Trial Management (CTM). Report to senior leadership and partner closely with Program Operations Leaders and Clinical Study Leads to own the preparation, organization, and execution of inspection readiness strategy in accordance with ICH/GCP guidelines and company SOPs. Serve as the primary CTM point of contact for all inspection‑related activities across internal studies and outsourced Clinical Research Organizations (CROs).

Responsibilities

• Act as project manager during mock, dry‑run, and actual inspections, leading the CTM team with follow‑up requests from inspection management.
• Provide guidance and support to Clinical Study Teams and functional areas, responding to Q&A sessions held by Inspection Management and following up on action items.
• Support ongoing CTM activities related to Trial Master File (TMF) health and oversight, ensuring documentation is produced and maintained.
• Track inspection readiness meetings, action items, questions, and presentations with internal and CRO stakeholders until closure.
• Manage inspection action items throughout the lifecycle—pre‑inspection activities (readiness meetings, Q&A, storyboards) and post‑inspection tasks (remediation plans, timelines, documentation).
• Utilize AI‑powered applications (such as Claude and Microsoft Copilot) to draft, refine, and quality‑check executive summaries, inspection storyboards, response documents, CAPA narratives, TMF gap analysis, and executive communication.
• Lead continuous improvement initiatives to enhance operational excellence for inspection readiness.
• Coach, train, and manage direct reports, reviewing performance against quality and timeliness standards.
• Ensure supportive documentation is available to resolve action items and provide updates upon completion.

Qualifications

• BS/BA degree and 8+ years of relevant clinical experience.
• Clinical inspection experience strongly preferred.
• Strong knowledge of GCP, ICH guidelines, and clinical trial documentation.
• Experience managing complex, multi‑program clinical portfolios involving internal teams and CRO partners.
• Proficiency in using AI tools for documentation and process improvement.
• Excellent communication, coaching, and stakeholder management skills.
• Ability to travel up to 25% of the time.

Compensation & Benefits

• Salary Range (Canada): $150,500.00 – $245,500.00 annually.
• Comprehensive total rewards package including annual bonuses, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, insurance benefits, paid time off, and family support benefits.
• Competitive compensation and benefits tailored to the role and location.

Equal Opportunity Employer

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.