1. Acts as the local scientific expert for assigned clinical research activities, addressing questions from internal functions and external Japanese physicians and research scientists.

2.Drive assigned projects forward as Japan project team lead with Japan cross functional team members. Interact regularly with Global Development Team Lead to exchange project information including strategic aspects.

3. Provides scientific support to The Company functions including but not limited to Clinical Development, Clinical Operations, Biostatistics, Data Management, Medical Writing, Clinical Pharmacology and Medical Affairs.

4. Responsible for identifying, establishing and maintaining science-based relationships with Japanese therapeutic area experts to support The Company’s development programs.

5. Responsible for the design of Japanese clinical studies including authoring of study concepts and protocol synopses. Works with the Clinical Operations team for the development, finalization and amendment (as applicable) of study protocols.

6 Prepares and presents （if applicable） scientific information concerning The Company’s development programs internally and at external meetings as required.

7 Critically assesses requests from Japanese therapeutic area experts for clinical development studies, Investigator Sponsored Trials and Grant requests:

8 Responsible for drafting regulatory Briefing Documents and slide presentations for use at PMDA and MHLW meetings. Attends and presents The Company position at informal and official Consultation meetings with PMDA and MHLW.

9 Working with Regulatory Affairs and the respective GSI Project Team, prepares written responses to PMDA, MHLW and IRB queries.

10 Coordinates the preparation and/or review of regulatory documentation including but not limited to IND annual reports, IND safety reports, Investigator Brochures and J-NDAs.