どんな仕事かAIによる生成

The Clinical Pharmacology Manager contributes to Japan clinical development by providing scientific guidance from clinical pharmacology aspects. The role authors regulatory documents for submissions and PMDA meetings, supports due diligence assessments, and works with global counterparts, the Japan asset team, and cross-functional teams.

応募資格・募集要項・仕事内容を見る

応募資格

必須

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)

募集要項最終確認 11/4

職種: 臨床開発・薬事
雇用形態: Full-time
役職: Manager
給与: 記載なし
勤務地: 東京都Minato City
働き方: 記載なし
学歴: 大学卒業以上
掲載日: 2026/10/13 06:28（23日前）
最終確認: 2026/11/04 20:04（1日前）

仕事内容

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.

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