Senior Scientist_BioPharma

Support for clinical team, for example response to the inquiries on nonclinical studies in investigator’s meeting

Develop toxicology and safety pharmacology-strategy for Japan clinical develop plan (earlier projects that are still in clinical phase 0-2)

Having discussions on supplemental studies according to Japan regulatory and northeast Asian countries requirements with global counterpart function (Chemical Preclinical Safety(CPS)) and colleagues, if necessary

Collect and analyze information on regulatory topics, developmental situation of competitor in Japan and northeast Asian countries. Then provide that information to CPS and relevant members

Be responsible for answering questions and objections on pharmacology and preclinical safety (general & safety pharmacology, toxicology) matters from PMDA with global counterpart in Japanese considering development strategy

Be responsible for preparation of nonclinical part (general & safety pharmacology, toxicology and pharmacology) of investigator’s brochure in Japanese

Be responsible for providing non-clinical parts of regulatory dossier and/or CTD, especially general & safety pharmacology, toxicology and pharmacology, for J-NDA and northeast Asian countries under the partnership with global CPS.

Be responsible for an assigned global roles or global works from global CPS. Attend CPS-Japan and CPS PRM TC to share or to be shared information of ongoing tasks among global CPS and CPS Japan

Collaborate on global business development regarding new licensing-in compounds on toxicology and safety pharmacology

Gathering information on basic medicine by attending the annual meetings of academic societies and associations of pharmaceutical industries

Provide clinical team, medical Affairs and/or commercial divisions with information on fundamental knowledge of products