Clinical Pharmacology Manager

求人内容

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.

資格

•               Bachelor or Master’s Degree in a relevant field including pharmacy, biology, chemistry, pharmacology or related area (Ph.D is favorable)

•               At least 10-year experience in drug development or related area, and at least 5-year research experience in the area of Clinical Pharmacology or related area

•               At least 5 J-NDA experiences or publication(s) as the first author in international scientific articles

•               Fluent English communication skills (TOEIC 730 or more)

•               Excellent interpersonal skills

•              Ability to interact with functional representatives externally and internally and lead team(s)

その他の情報

アッヴィは、機会均等を重視する雇用主であり、誠実な企業活動、革新の推進、人々の生活への貢献、そして地域社会への貢献に努めています。雇用機会均等に向けて、障がいを持つ方々も積極的に支援しています。