Purpose Statement:

•               Contribute to Japan clinical development by providing scientific guide from clinical pharmacology aspects.

•               Author regulatory documents for submission and for meetings with PMDA closely collaborating with global counterpart and Japan asset team.

•               Take a lead on collaboration with cross-functional teams and bring innovations to clinical development and future in clinical pharmacology group.

Major Responsibilities:

1.             Represent from Clinical Pharmacology and drive projects forward in clinical development by providing clinical pharmacology aspects cooperated with global counterpart and Japan asset team.

2.             Author regulatory documents including CTDs, briefing book and responses to PMDA interactions, cooperating with the relevant stakeholders.

3.             Support due diligence assessments from clinical pharmacology aspects.

4.             Drive discussions in the field of clinical pharmacology to increase clinical pharmacology expertise.

5.             Participate external scientific meetings to update the state-of-the-art science to the team.