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

Clinical Scientist (CS)

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)

Qualification (Experience & Skill etc.)

Experience

Mandatory:

Experience of working on drug development in pharmaceutical industry

Nice to have:

Clinical science strategy planning in drug developmentNegotiations with external expertsPlanning of clinical science strategies as a Japan clinical science representative at the cross-functional teamQuality of knowledge on drug development strategy and clinical scienceExperience on negotiation with PMDA/MHLW, and getting JNDA/sJNDA approval and supporting launch activities (Career Level E)

License

Mandatory:

Life Science related bachelor's degree required

Nice to have:

Doctor of Philosophy preferred

Skill-set

Mandatory:

Assertive communication skillMedical writing skillProject management skillLogical thinking skillStrategic influencing skillLeadership capabilityConceptual thinking skillNegotiation skillAbility to work in a complex, business critical and high-profile environment building credibility in ambiguous situationsRapid adaptability to a new environment

Language

Mandatory:

English： Business English (Native level)

Career Level

E or D

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 authorization and employment eligibility verification requirements.