Senior Manager, Clinical Study Lead

We are hiring a Senior Clinical Study Lead (CSL) to join our dynamic Clinical Trial Management team in Tokyo, Japan. As a pivotal member of our team, you will lead large-scale and complex clinical trials globally and regionally, ensuring excellence in execution and compliance with industry standards. This role offers opportunities to contribute to innovative solutions and drive process improvements, making an impactful difference in clinical study operations.

A Typical Day:
As a Senior Clinical Study Lead, you will:

• Lead cross-functional study teams to ensure clinical study delivery.

• Provide operational input into protocol development and oversee study-specific documentation.

• Manage clinical trial systems such as CTMS and TMF, ensuring compliance with registry requirements.

• Identify outsourcing needs, engage vendors, and oversee contracting and management.

• Develop and manage study budgets and timelines while mitigating risks.

• Oversee site evaluation, selection, and activation, including investigator meetings.

• Monitor patient recruitment strategies and ensure data quality.

• Supervise study close-out activities, including database lock and reconciliation of vendor contracts.

• Contribute to clinical study report writing and process improvement initiatives.

This Role May Be For You If:

• You thrive in leadership roles, with the ability to build and guide productive study teams.

• You excel in managing complex clinical trials and balancing direct leadership with oversight responsibilities.

• You have advanced technical proficiency in trial management systems and MS applications such as Excel, PowerPoint, and Word.

• You possess exceptional communication skills, both written and verbal, and are adept at influencing and negotiating across diverse stakeholders.

• You are proactive, self-disciplined, and skilled at prioritizing tasks to meet deadlines effectively.

• You demonstrate expertise in global clinical trial operations and regulatory guidelines.

• You are passionate about driving innovation and continuous improvement in clinical study execution.

To Be Considered:
Candidates must possess a Bachelor’s degree and have at least 8 years of relevant industry experience. Advanced project management skills, cross-functional leadership, and knowledge of ICH/GCP guidelines are essential. Preferred qualifications include line management experience and proficiency in vendor management.

This is your opportunity to lead groundbreaking clinical trials and contribute to the advancement of global healthcare. Join us and be part of a team dedicated to excellence and innovation in clinical trial management.

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.