Manager Medical Study Operations
Regeneron
Village of Sleepy Hollow, New York
Full-Time
$114,800
RemoteManager
As a Manager, Medical Study Operations you are responsible for all operational aspects of Global Medical Affairs Oncology, including Investigator-Initiated Studies (IIS), Research Collaborations (RC), and Data Transparency requests across multiple products and new molecules. ensuring compliance with applicable standards and regulations.
This position will require you to be on-site 4 days/week at our Sleepy Hollow, NY offices. If eligible, we can offer relocation benefits. We cannot offer a remote work option.
A typical may include the following:
• Manage multiple projects/programs, including IIS, Research Collaborations, and Data Transparency, with moderate direction.
• Ensure proposals align with Areas of Interest, are complete, and reviewed by the appropriate governing bodies. Obtain all necessary approvals, including those from the Medical Affairs Review Committee (MARC), Collaborator/Partners, and Senior Management, for both original proposals and amendments.
• Facilitate meetings and committees, including setting agendas, driving goals, documenting outcomes, and ensuring follow-up on action items. Coordinate scientific meetings with external investigators and the Field Medical Team.
• Track and report study progress, data delivery, program impact, and other relevant metrics.
• Ensure collection, tracking, and archiving of all relevant documents, including regulatory submissions, IRB/EC approvals, and Health Authority communications.
• Ensure patent reviews, due diligence (e.g., OIG exclusion list, FDA debarment), and background checks for compliance.
• Collaborate with Site Budget & Contracting, Legal, Procurement, and Sponsor Institution to ensure agreement meets study requirements.
• Oversee study budgets, including Fair Market Value (FMV) analysis, approvals, and purchase orders (POs). Manage POs, achievements, invoicing, accruals, projections, and budget planning. Handle budget changes, reforecasts, and reconciliations while ensuring effective communication with partners.
• Plan and coordinate drug campaigns with Drug Supply Functions, ensuring compliance with packaging, labeling, and country-specific requirements.
• Manage drug shipments, resupply, expiry, quarantines, and destruction of unusable products.
• Ensures timely receipt and reconciliation of Serious Adverse Events (SAEs) and Investigator Alert Letters (IAL) in compliance with regulatory requirements.
• Coordinate internal review of publications, consolidate feedback, and document actions taken.
• Ensure data capture in study management tools and document repositories for audit readiness.
• Adhere to all relevant processes, training, and SOPs to ensure consistency, efficiency, and compliance.
To be considered a minimum of BA/BS degree in a related field with 7+ years of industry or relevant professional experience in clinical research. Experience in oncology and/or antibody research is a plus. Experience with Investigated Initiated Studies is 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)