Senior Manager Clinical Study Inspection Readiness

Senior Manager, Clinical Study Inspection Readiness Leads all Good Clinical Practice (GCP) inspection readiness activities for one or more assigned clinical programs within Clinical Trial Management (CTM). Reporting to senior leadership and partnering closely with Program Operations Leaders (POLs) and Clinical Study Leads (CSLs), this role owns the preparation, organization, and execution of inspection readiness strategy in accordance with ICH/GCP guidelines, Regeneron SOPs, Work Instructions (WIs), and Business Practice Tools (BPTs). The role provides inspection readiness leadership across both internally sourced studies and those outsourced to CROs, serving as the primary CTM point of contact for all inspection‑related activities. This role is expected to leverage AI‑powered tools including large language model (LLM) applications such as Claude to accelerate deliverable production, strengthen documentation quality, and drive continuous improvement in inspection readiness operations, with all AI‑assisted outputs subject to human review and full GCP compliance. Typical Day in This Role Serve as: CTM Inspection Readiness point of contact leading GCP inspection readiness programs across complex, multi‑program clinical portfolios involving both internal teams and CRO partners, and Inspection Management. Project manager during the inspection process (mock, dry run and/or actual) and assist, or lead, the CTM team with follow‑up requests from the inspector/inspection management team during mock and actual inspection(s). Provide guidance and support to Clinical Trial Management as follows: Work with Clinical Study Team (CST) and functional areas to support CTM in providing responses to the Q&A sessions held by Inspection Management for Inspection Readiness, support action‑item follow‑up as needed. Support ongoing CTM activities related to TMF health and oversight. Provide guidance on compliance and regulations and ensure CTM staff study teams are following targeted SOPs, Business Practice Tools, and Working Instructions during the study. Track inspection readiness meetings, CTM Inspection action items, questions and answers, storyboards, and presentation requests with key stakeholders (internal/CRO) until closure. Manage CTM inspection action items throughout the inspection lifecycle, from pre‑inspection activities (readiness meetings, Q&A, storyboards, presentation requests with internal/CRO stakeholders) to post‑inspection tasks (remediation plans, timelines, documentation, closure updates), ensuring prompt resolution and a complete audit trail. Support the CTM processes related to Inspection Readiness to ensure that appropriate documentation is produced/maintained in the TMF, including frequently requested documents and early identification of Sites of Interest (SOI). Work with the Clinical Study Leads, CRO and/or Vendor team(s) to obtain all the necessary essential and regulatory documents for all study/sites as part of the IRR activities. Track CTM action items assigned following inspections to ensure action plans are in place for remediation, as needed, with timelines for completion. Ensure supportive documentation is available to support resolution of the action items and provides updates as needed on the resolution. May lead and participate in internal process improvement projects/initiatives to continuously improve operational excellence to support inspection readiness. Utilize AI‑powered applications (e.g., Claude, Microsoft Copilot) to draft, refine, and quality‑check executive summaries, inspection storyboards, response documents, and Corrective and Preventive Action (CAPA) narratives, TMF gap analysis, action‑item tracking, and executive communication. Establish goals, expectations, and accountabilities for direct reports. Regularly review performance in respect to quality and timeliness standards according to Regeneron SOPs and working procedures. Responsible for coaching, managing training and leading the direct reports. May require up to 25% travel. Qualifications In order to be considered qualified for this role, a minimum of a BS/BA degree and 8+ years relevant clinical experience. Clinical Inspection experience heavily preferred. Salary Range (annually) $150,500.00 - $245,500.00 Equal Employment Opportunity Statement 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. #J-18808-Ljbffr Initial Therapeutics, Inc.