仕事内容
The 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 International Council for Harmonization (ICH)/GCP guidelines, Regeneron Standard Operating Procedures (SOPs), Work Instructions (WIs), and Business Practice Tools (BPTs). The role provides inspection readiness leadership across both internally sourced studies and those outsourced to Clinical Research Organizations (CROs), serving as the primary CTM point of contact for all inspection-related activities. This role is expected to leverage Artificial Intelligence (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
A typical day in this role looks like:
Serve as:
- CTM Inspection Readiness point of contact leading GCP inspection readiness programs across complex, multi-program clinical portfolios involving both internal teams including CRO partners, and Inspection Management.
- Project manager during the inspection process (mock, dry run and/or actual) and assist, and/or lead (as needed) 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 during study, 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&As, 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 to 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.
- Establishing goals, expectations, and accountabilities for direct reports. Regularly reviews 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
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.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries’ specific benefits, please speak to your recruiter.
Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location.
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, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
Salary Range (annually)