About this role
Are you ready to make a meaningful impact on clinical development programs in Japan? At Regeneron, we are seeking a dedicated Medical Director, Clinical Sciences, to join our dynamic team. In this pivotal role, you will collaborate closely with the Japan Clinical Development Lead (J-CDL) to advance scientific and clinical aspects of our programs. From contributing to global clinical teams to supporting regulatory filings, your expertise will drive innovation and deliver results that matter.
Join us in shaping the future of clinical development, where your skills and insights will play a vital role in transforming lives.
A Typical Day:
As the Medical Director, Clinical Sciences, your day will be filled with impactful activities, such as:
Supporting the clinical components of assigned clinical development programs (CDPs) in Japan.
Providing clinical and scientific input for regulatory documents, including J-NDA/J-CTD submissions.
Contributing to the development and adaptation of clinical trial protocols and related documentation for Japan-specific needs.
Collaborating with cross-functional teams to ensure clinical feasibility and address local medical needs in global studies.
Participating in investigator meetings, site initiation visits, and vendor kick-off meetings to drive study execution.
Offering medical/scientific input to resolve issues during study conduct and execution.
Staying current on scientific advancements in therapeutic areas and representing the company at national and international conferences.
Building and maintaining relationships with key opinion leaders (KOLs) and investigator sites.
This Role May Be For You If:
You have a strong understanding of the drug development process, clinical trial design, and good clinical practice (GCP).
You excel in both Japanese and English, with business-level proficiency in English communication.
You enjoy collaborating across cross-functional teams, bringing diplomacy and influence to your interactions.
You are detail-oriented and possess exceptional analytical and problem-solving skills.
You thrive in dynamic environments and are adept at managing regulatory interactions effectively.
You value diversity, different perspectives, and are committed to fostering inclusive teamwork.
To Be Considered:
We are looking for candidates with the following qualifications:
Required: MD or MD/PhD with at least 5 years of pharmaceutical industry experience, including 3 years of clinical development experience.
Expertise in regulatory filings and clinical document preparation, particularly CTN and J-NDA/J-CTD submissions.
Proven ability in protocol design, clinical data review, and familiarity with medical monitoring activities.
Strong knowledge of Phase I–III clinical trial design and objectives.
Preferred: Experience with clinical feasibility assessments and Japan-specific enrollment considerations.
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.
About Regeneron
Biotechnology company developing antibody-based therapies for eye disease, immunology, and oncology. Headquartered in Tarrytown, NY.
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