Medical Director, Clinical Sciences

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.

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