Job Summary

• The Clinical Pharmacology (CP) Senior Scientist role within Japan Clinical Pharmacology and Pharmacometrics (CPP) 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.
• Responsible for clinical study plan, PK and PK/PD analysis, and documentation of a Japanese Phase 1 study; designs and writes clinical study protocols, analysis plans, and clinical reports of a Japanese phase I study or more complex CP study with mentoring.
• Integrates all available data (both clinical and nonclinical data) to clinical development strategy from CP point of view and evaluates and applies new data and data analyses to refine studies in the development plan.

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Skills & Requirements

Key Requirements

• PhD or equivalent with minimum 2 years of relevant experience
• 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
• Ability to interpret PK and PK/PD results and prepare presentations
• Strong oral and written communication skills in both Japanese and English

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