Senior 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 Senior Clinical Study Lead to join our Clinical Trial Management team, supporting our global, regional and country studies in a hybrid work mode. In this role, you will lead complex clinical trials from study design through close-out while collaborating with cross-functional study teams, vendors and clinical research organizations. 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.

Discover your role:

Lead cross-functional teams and global, regional or country trial delivery from design through close-out.

Own timelines, budgets, risks, protocol input and study documentation under ICH/GCP and Regeneron SOPs.

Oversee CTMS, TMF, trial registry compliance, vendors, CROs and audit or inspection readiness.

Direct feasibility, site selection, activation, monitoring, investigator meetings and patient recruitment strategies.

Monitor data quality, queries, deviations, supplies, accountability and trial performance against agreed metrics.

Manage close-out, database lock, reconciliations, clinical study reports, CAPAs and lessons learned.

You drive continuous improvement, innovative study execution and effective cross-functional collaboration.

Lead CTM staff deliverables and, when assigned, supervision or unmasked study activities.

This role requires:

Bachelor’s degree and at least eight years of relevant industry experience.

Extensive global clinical trial operations experience and knowledge of ICH/GCP and regulatory requirements.

Advanced project, budget and vendor management, cross-functional leadership and organizational skills.

Advanced proficiency with trial management systems, Microsoft applications, IVRS/IWRS and EDC.

Expert data-driven planning, problem-solving, negotiation, communication, prioritization and stakeholder influence.

Ability to build and develop study teams; line management experience is preferred.

Awareness of relevant industry trends and a proactive, self-disciplined approach.

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.