クリニカル サイエンティスト, ワクチン・リサーチ部

1. Overall Responsibilities

• Provides expertise in clinical science and works with Japan Clinical Leaders to execute clinical studies and obtain approval for projects in Japan. Serves as a role for junior colleagues to acquire knowledge, skills, and experience in clinical development and establish the basis to subsequently work in various roles within Development Japan. Works with the Head of Vaccine Research to promote clinical excellence, streamline processes related to clinical development, and ensure alignment between Vaccine Research and the global organization.

• Provide expertise in clinical science and works with Japan Clinical Leaders to execute clinical programs that span from Phase 1 studies through approvals and provide support for products after approval in Japan
• Prepare and review clinical documents (e.g. full protocol, protocol amendment, informed consent document, case report form, investigator's brochure) and related documents
• Support Japan Clinical Leader to prepare other clinical and regulatory documents (e.g. clinical study report, briefing document, common technical document, query response) and to conduct clinical studies

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• Scientific background in education (Master's degree or higher is preferred)
• At least 3 years of experience in clinical development including clinical trials and/or regulatory submissions
• Writing and communication skills in both Japanese and English