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【R&D】Clinical Scientist(Hematology & Early Development Oncology TA Division)

Lieu Osaka, Ōsaka-fu, Japon Kita-ku, Préfecture de Tokyo, Japon Job ID R-151842 Date de publication 01/18/2023

■ 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. 

For more information about responsibilities/accountabilities, refer to the full version of the Job Description for Clinical Scientist

■ 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
・Business English
・Project management skill
・Logical thinking skill
・Strategic influencing skill
・Leadership capability
・onceptual 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

日本語: Native level

【キャリアレベル / Career Level】

D or E

【勤務地 / Work Location】

Osaka or Tokyo

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.

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