Clinical Pharmacology Manager
Clinical Pharmacology Manager
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Job Description
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 :
Qualifications:
Bachelor or Masters 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)
Additional Information :
AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more visit & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
No
Employment Type :
Full-time
Employment Type
Full-time
