Clinical Pharmacology Manager

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 – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. 

Mission:

・ Take a lead to develop the Clinical Pharmacology(CP) related part of Briefing Book (BB) for PMDA consultation and Investigator's Brochure (IB) for the clinical studies conducted in Japan.
・ Develop CTD in collaboration with AST and take a lead to respond to PMDA's inquiries for the registration in Japan.
・ Continuously provide inputs required for Japan development and submission to global counterparts (CPPM) to become cooperative partners.
・ Take a lead to increase the scientific skills in Japan Development

Major Responsibilities:
1. Report to CP Group Manager in a timely manner.
2. Prepare documents for clinical studies and for registration in Japan, and respond inquiries from PMDA and clinical sites. Provide advice to CP members about CP related outcomes (i.e. strategy and documents, etc.).
3. Closely exchange the relevant information with AST, and advise to AST from the Japanese regulatory and scientific points of view. Manage communications and collaborations between JPT and AST to make schedules and plans.
4. Evaluate and provide information regarding compounds at an early stage of development or candidates for license-in.
5. Lead regular session to increase the scientific skills in CP areas.
6. Create and execute the career development plan under agreement with CP group manager.
7. Attend external trainings and obtain latest information.

Qualifications:
• At least 10-year experience in drug development or related area.
• 5-year or more research experience in the area of Clinical Pharmacology or related area..
• At least five J-NDA experiences or first-author- international scientific articles
• English communication skill (TOEIC 730 or more)
• A person who has graduated from a department of or completed a master’s course for pharmacy, biology, chemistry, pharmacology or related area, or favorably winning certified person (Ph.D.).

AbbVieは、誠実な事業運営、イノベーション推進、人々の生活の変革、地域社会への貢献、そしてダイバーシティ＆インクルージョンの促進などに尽力しています。AbbVieの採用方針は、人種や肌の色、宗教、国籍、年齢、性別（妊娠を含む）、身体的・精神的障がい、病気、遺伝情報、性同一性または表現、性的指向、婚姻状況、退役軍人やその他法的に保護されたグループに属するかどうか等に関わらず、高い能力を持つ優秀人財を従業員や候補者として差別することなく雇用することです。