Senior Manager Clinical Research

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募集要項

会社概要

同社はアメリカを拠点とする親会社を持つ大手ライフサイエンス企業です。主に医薬品やワクチンの研究開発、輸入、製造、販売を事業として展開しています。人々の健康を守り、豊かな人生を築く手助けをすることで、同社の使命・目標に向かって日々奮闘し、日本の満たされていない医療ニーズにいち早く応えてゆきます。さらに、さまざまなプログラムやパートナーシップを通じ医薬品を必要とする人々への製品寄付や供給を行い、医薬品へのアクセスを推進する活動に積極的に取り組んでいます。

業務内容

• Create Japan clinical development plan within global development strategy
• Lead clinical studies in Japan from scientific perspective
• Lead PMDA consultation related to Japan clinical development
• Develop clinical study protocols
• Support development of other study-related materials (e.g. draft Informed Consent, Case Report Form, study related SOP, etc.)
• Support study operations
• Perform medical monitoring of clinical study data
• Develop Clinical Study Reports
• Lead clinical related part of approval review
• Develop clinical sections of the Common Technical Document (CTD)
• Develop responses for clinical related inquiries
• Make presentations at scientific meetings and/or author manuscripts on clinical trials, or provide necessary support for them

応募条件

Requirements-Must:

• Clinical development experience in pharmaceutical company (5 year or more).
• Master degree or Ph.D in medical, pharmaceuticals sciences or life sciences.
• Frontier spirits and leadership to challenge unexperienced area
• Soft skills essential for a close collaboration with Japan/ex-Japan team members as well as other internal/external stakeholders
• English level equivalent to TOEIC score 800 or above

Requirements-Preferred:

• Experience in drug clinical development
• Any work experience related to biologics, and/or tissue/ cellular products

給与

1200 - 1800 万円

勤務地

東京