■Job Summary

The Clinical Pharmacology Modeling & Simulation Manager will be responsible for developing and implementing clinical pharmacology strategies to support drug development programs. The successful candidate will be local representative of CPMS for the assigned programs, and provide clinical pharmacology expertise to global and local teams.

Key Responsibilities

+ Optimize clinical pharmacology components in local drug developments.
+ Collaborate with global and local cross-functional teams.
+ Apply clinical pharmacology principles and regulatory requirements to local drug development.
+ Effectively Communicate clinical pharmacology results to internal and external stakeholders.
+ Contribute to regulatory submissions and interactions with PMDA.

■Basic Qualifications

+ Knowledge/Skill
+ Strong knowledge of ADME and pharmacodynamics.
+ Familiarity with local regulatory documents in CTNs, J-NDAs, PMDA consultations
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