Job Summary

• The Clinical Pharmacology (CP) Senior Scientist role is to apply and promote CP knowledge, including pharmacokinetics (PK) / pharmacodynamics (PD) analyses and principles of model-based drug development in the programs for all stages of drug development in Japan.
• Responsibilities include contribution in Japan Project Teams independently, designing and writing clinical study protocols, analysis plans, and clinical reports, and integrating all available data to clinical development strategy from a CP point of view.
• The role requires collaboration with Pharmacometrics leaders in overall CP development strategy, design of clinical studies including modeling and simulation-based assessments, and representing CPP at regulatory interactions in Japan.

Matching Summary

Skills & Requirements

Key Requirements

• PhD or equivalent with minimum 2 years of relevant experiences; or MS or equivalent with minimum 6 years of relevant experience
• Good knowledge and experience of drug development in one or multiple TAs
• Comprehensive understanding of requirements for various regulatory documents in Japan
• Knowledge of drug development, regulatory requirements and guidelines expanded to multiple therapeutic modalities, to handle routine and non-routine work for FDA and EMA in addition to PMDA / MHLW
• Ability to interpret PK and PK/PD results and prepare presentations to communicate findings effectively
• Strong oral and written communication skills in both Japanese and English

Work Rights