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 important responsibilities include: 
PMDA/MHLW interaction: Co-develop the documents for regulatory interactions such as BD for regulatory consultation, query responses, Sakigake application, ODD application, etc, as a clinical development expert through collaboration Project Physician.
JNDA: Lead JNDA clinical satellite team activities and be point of contact to JNDA Lead and global CPT.
KEE management: Act as a key point of contact for clinical development related relationship with external experts.

The measure of success includes:

1) The quality and quantity of medical/clinical deliverables mentioned above for AZ ensures patients access to valuable medicines.

2) Leadership and appropriate behaviors. 

■応募条件

【必須条件】

Experience of working on drug development in pharmaceutical industryLife Science related bachelor’s degreeAssertive 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日本語：Native level英語：Business English（英語でのBusiness discussionが可能なレベル、TOEIC 750点以上を目安）

【歓迎条件 / Nice to have】

Experience of working on drug development in OncologyExperience of working on drug development in Radioconjugate projectsClinical 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 activitiesDoctor of Philosophy

【勤務地】

Osaka or Tokyo

【キャリアレベル】

D or E

Date Posted

06-8月-2025

Closing 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.