Supports Japan and regional clinical studies as a medical decision-maker, reviewing safety, eligibility, protocol compliance and data while advising study teams and internal stakeholders.
About this role
This Senior Manager role is the Japan Clinical Lead in Innovative Medicine R&D’s global Therapeutic Area Oncology team. It brings Japanese clinical insight into global development strategy and may serve as Study Responsible Physician or Scientist for assigned studies.
The work covers early- and late-development oncology programs, including study start-up, oversight and reporting, PMDA/MHLW interactions, clinical regulatory documents, JNDA support, and protocol, efficacy, safety and data review. The lead coordinates with Clinical Operations, Data Management, Statistics and Regulatory, supports site and enrollment responses, and may mentor clinical project physicians and scientists.
Applicants must have a bachelor’s degree or higher in biology, pharmacology or a related scientific specialty, at least five years of clinical research experience in pharmaceutical clinical development or equivalent academia experience, and knowledge of Good Clinical Practice and oncology-trial regulatory requirements. Working knowledge of Excel and Word, fluent written and spoken English, and native-level Japanese are also required.
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