Senior Director, Country Operations Lead

We are seeking a dedicated and experienced Senior Director, Country Operations Lead to join our Clinical Trial Management team in Japan. This role is pivotal in driving the operational strategy and execution of clinical trials within the country, ensuring compliance with ICH/GCP, local guidelines, and company SOPs. If you are passionate about clinical research and have a consistent track record in leading clinical operations, we invite you to be part of our dynamic team.

A Typical Day:

• Develop and implement study-specific country-level operational plans, including timelines and enrollment commitments.

• Adapt global program materials to meet local requirements, such as monitoring plans and patient recruitment materials.

• Communicate country status and updates to key partners and relevant systems.

• Lead all aspects of site-level goal setting and deliverables for clinical sites within Japan.

• Provide expert input into the country-level investigator site selection process and study start-up activities.

• Support and coordinate ancillary vendor activities, including laboratories and equipment provisioning.

• Manage local CRO functional oversight and budget critical issues.

• Ensure inspection readiness and participate in regulatory authority inspections as needed.

• Lead and review country-level risk mitigation activities to ensure studies deliver to plan.

This Role May Be For You If:

• You have a proactive and self-disciplined approach, with the ability to meet deadlines and prioritize tasks effectively.

• You possess strong analytical skills and a data-driven approach to planning and problem-solving.

• You excel in building and leading productive teams, with demonstrated mentoring and coaching abilities.

• You are experienced in handling and coordinating external vendors, such as CROs and central labs.

To Be Considered:

Candidates must have a Bachelor's degree and a minimum of 12-15 years of relevant industry experience, including 8 years within the biopharmaceutical clinical research field. Advanced degrees may be considered in lieu of relevant experience. Fluency in English and Japanese, deep understanding of GCP, ICH, and local country regulations and guidelines are crucial.

Join us in making a meaningful impact on clinical research and patient outcomes. Apply today to be part of our innovative and collaborative team.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!

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.