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Regeneron Pharmaceuticals

Develops biopharmaceutical therapies for serious diseases

Medical Director - Clinical Sciences

Clinical Research OperationsConfirmed live in the last 24 hours
Full-timeTokyo, JapanNo salary listed

About the Job

Requirements

  • An MD or MD/PhD degree is required.
  • At least 5 years of pharmaceutical industry experience, including at least 3 years in clinical development, is required.
  • Experience contributing to regulatory filings and clinical documents, particularly CTN and J-NDA/J-CTD submissions, is required.
  • Clinical trial design expertise across Phase I, II, and III studies is required.
  • Experience with protocol design, clinical data review, and medical monitoring activities is required.
  • Business-level English proficiency and strong communication skills in Japanese and English are required.
  • Strong analytical, problem-solving, and influencing skills are required.
  • Ability to work effectively within matrix environments and cross-functional teams is required.
  • Strong presentation and medical writing skills are required.

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 against local medical needs for Japan's participation in global studies and provide enrollment input.
  • Build relationships with KOLs and investigator sites alongside 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.

About the Company

Regeneron Pharmaceuticals

Develops biopharmaceutical therapies for serious diseases

Regeneron Pharmaceuticals develops and commercializes medicines for serious diseases, with a focus on cancer, eye diseases, allergic and inflammatory diseases, and infectious diseases. Its products come from using proprietary research capabilities and technologies to discover and develop therapies, often in collaboration with academic, research, and industry partners. Revenue comes from selling approved medicines and from licensing its technologies and entering co-development and co-commercialization partnerships. The company works with healthcare providers and regulators to ensure treatment delivery and safety. Its goal is to improve patient outcomes by bringing life-transforming medicines to market through rigorous R&D and strategic collaborations, maintaining leadership in biopharmaceutical innovation.

Company size
10,001+
Company stage
IPO
Headquarters
Town of Mount Pleasant, New York
Founded
1988

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