Manager, Clinical Study Lead

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 Clinical Study Lead to join our Clinical Trial Management team, supporting our Japan operations in a hybrid work mode. In this role, you will lead assigned clinical trials from study design through close-out while collaborating with cross-functional study teams, vendors and leadership. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

When & where:

Tokyo, Japan

Hybrid

Up to 25% travel may be required.

Discover your role:

• Lead cross-functional study teams and global, regional or country execution of assigned clinical trials.
• Shape protocols, study documentation, feasibility, site selection, investigator meetings and recruitment strategies.
• Manage timelines, budgets, risks, vendors, supplies, study systems, activation, monitoring and data quality.
• Maintain Clinical Trial Management System and Trial Master File readiness, including registry, audit and inspection compliance.
• Escalate study issues and implement corrective actions with Program Operations Lead, Country Operations Lead and stakeholders.
• Lead close-out, including database lock, vendor reconciliation, budgets, Trial Master File and study drug accountability.
• Support study reports, lessons learned, staff deliverables, process improvement, unmasked activities and potential line management.
• You use data-driven thinking to strengthen study execution and continuous improvement.

This role requires:

• Bachelor’s degree and at least six years of relevant industry experience.
• Global clinical trial operations experience, including protocols, key study documents and budget and vendor management.
• Knowledge of International Council for Harmonisation Good Clinical Practice and applicable regulatory guidelines.
• Proficiency with trial management systems, Microsoft applications, Interactive Voice Response Systems and electronic data capture.
• Project management, cross-functional leadership, organization, communication, influencing and negotiation skills.
• Ability to implement operational strategy, meet deadlines, prioritize effectively and build productive study teams.
• Industry awareness, proactive self-discipline and a data-driven approach to planning, execution and problem-solving.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! 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. If you have any questions, please speak with your recruiter.

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 on‑site. Please speak with your recruiter and hiring manager for more information about on‑site 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.