Clinical Pharmacology Manager

Role Summary

企業概要

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on LinkedIn, Facebook , Instagram , X and YouTube.

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.

Responsibilities

• Represent from Clinical Pharmacology and drive projects forward in clinical development by providing clinical pharmacology aspects cooperated with global counterpart and Japan asset team.
• Author regulatory documents including CTDs, briefing book and responses to PMDA interactions, cooperating with the relevant stakeholders.
• Support due diligence assessments from clinical pharmacology aspects.
• Drive discussions in the field of clinical pharmacology to increase clinical pharmacology expertise.
• 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。

About the Company

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on LinkedIn, Facebook , Instagram , X and YouTube.

R&D Process Engineering Organization, a part of AbbVie’s Development Sciences organization, is responsible for designing and developing scalable processes to make drug substances and drug products, including synthetics molecules, antibody drug conjugates (ADCs) and genetic medicines, throughout pre-clinical and clinical development stages. Process Engineering also partners with Biologics CMC (Chemistry, Manufacturing, and Controls) Development and Aesthetics R&D functions to provide active engineering support to enable robust process scale-up and manufacturing of biologics drug substances and drug products including toxins and cosmetic active ingredients (CAIs). It drives the development of innovative engineering technologies and creates valuable intellectual property through the composition of matter and chemical/bio-chemical processes resulting in cost-effective commercial manufacturing processes for quality products.