AstraZenecaR&DClinical Scientist, R&D Hematology & Early Development Oncology TA Division
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Job Location:
Monthly Salary:
Posted on:
16 hours ago
Vacancies:
1 Vacancy
Job Summary
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.
- Guiding and supporting other Clinical Scientists at career level D. (Career Level Eの場合)
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 (Career Level Eの場合は必須)
資格 / License
必須 / Mandatory
Life Science related bachelors 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
Date Posted
26-1月-2026Closing Date
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 authorization and employment eligibility verification requirements.
Required Experience:
IC
Key Skills
- Laboratory Experience
- Vendor Management
- Design Controls
- C/C++
- FDA Regulations
- Intellectual Property Law
- ISO 13485
- Research Experience
- SolidWorks
- Research & Development
- Internet Of Things
- Product Development
About Company
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, ... View more
