【AstraZeneca】【R&D】Clinical Scientist, R&D Hematology & Early Development Oncology TA Division

■ 職務内容 / Job Description

Clinical Scientist (CS) is a clinical project lead with strong experience in multidisciplinary aspects of drug development and is accountable/responsible for generating clinical development strategy, designing clinical development options, and delivering successful clinical development programs for responsible AZ assets in Japan. 
His/Her accountability/responsibility is balanced between project-level and study-level activities, depending on his/her experience and expertise, in order to achieve deliveries of both projects and studies. 

Other major responsibilities/accountabilities include but are not limited to:

• Co-developing the documents for regulatory interactions such as BD for regulatory consultation, query responses, Sakigake application, ODD application, etc, 
• Authoring clinical/medical part of CTD and responses to queries 
• Acting as a key point of contact for clinical development related relationship with external experts. 
• Leading development of clinical science part of clinical trial documents, and providing support for the Study Level Safety Review activity, for Japanese standalone development projects,
• Inputting to publication strategy and contents/quality of publications. 

■ 応募資格（経験、資格等）/ Qualification (Experience & Skill etc.)

【経験 / Experience】

＜必須 / Mandatory＞

Experience of working on drug development in pharmaceutical industry

＜歓迎 / Nice to have＞

・Clinical science strategy planning in drug development
・Negotiations with external experts
・Planning of clinical science strategies as a Japan clinical science representative at the cross-functional team
・Quality of knowledge on drug development strategy and clinical science
・Experience on negotiation with PMDA/MHLW, and getting JNDA/sJNDA approval and supporting launch activities

【資格 / License】

＜必須 / Mandatory＞

Life Science related bachelor’s degree required

＜歓迎 / Nice to have＞

Doctor of Philosophy preferred

【能力 / Skill-set】

＜必須 / Mandatory＞

・Assertive communication skill
・Medical writing skill
・Project management skill
・Logical thinking skill
・Strategic influencing skill
・Leadership capability
・Conceptual thinking skill
・Negotiation skill
・Ability to work in a complex, business critical and high-profile environment building credibility in ambiguous situations
・Rapid adaptability to a new environment

【語学 / Language】

＜必須 / Mandatory＞

英語 English： Business English (グローバルチームとの会議を実施できるレベル)

日本語: Native level

【キャリアレベル / Career Level】

E or D

【勤務地 / Work Location】

Osaka or Tokyo