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Clinical Pharmacology Manager
AbbVieTokyo, Japan2日前
職務内容の詳細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)
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.
Qualifications :
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Manager • Tokyo, Japan