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About the Role
Support the scientific and clinical aspects of assigned clinical development programs while collaborating with the Global Clinical Sub Team and cross-functional partners. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.
Responsibilities
- Support the Japan Clinical Development Lead in clinical components of assigned development programs and contribute to the Global Clinical Sub Team
- Adapt clinical trial protocols, amendments, CRFs, IRB applications, informed consent forms, and recruitment materials for Japan-specific requirements
- Provide clinical input for regulatory documents including CTN submissions, Investigator Brochures, J-NDA/J-CTD submissions, and PMDA responses
- Review clinical data and prepare study reports, abstracts, manuscripts, and presentations
- Assess clinical feasibility with local medical needs for Japan's participation in global studies and provide enrollment input
- Build KOL and investigator site relationships with Clinical Trial Liaisons, Clinical Operations, and Medical Affairs teams
- Stay current on scientific progress in assigned therapeutic areas and represent the company at conferences
- Collaborate with regulatory affairs, project management, clinical operations, medical affairs, and Global Patient Safety teams
Requirements
- MD or MD/PhD degree
- Minimum 5 years pharmaceutical industry experience with at least 3 years in clinical development
- Experience contributing to regulatory filings and clinical documents, particularly CTN and J-NDA/J-CTD submissions
- Clinical trial design expertise across Phase I, II, and III studies
- Experience with protocol design, clinical data review, and medical monitoring activities
- Business-level English proficiency with strong communication skills in Japanese and English
- Strong analytical, problem-solving, and influencing skills
- Ability to work effectively within matrix environments and cross-functional teams
- Strong presentation and medical writing skills
Skills
- Analytical skills
- Problem-solving skills
- Influencing skills
- Presentation skills
- Medical writing skills
Location
- Japan Local Country Office
Work Type
- Hybrid
Experience Level
- Minimum 5 years pharmaceutical industry experience
- At least 3 years in clinical development
Education Level
- MD or MD/PhD degree
Benefits
- 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
- Family support benefits
About the Company
- Regeneron uses science and innovation to develop life-changing medicines for people with serious diseases.
- We are committed to building a workplace with an inclusive culture.
Equal Opportunity
- 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.