【AstraZeneca】【R&D】Translational Scientist, Translational Science Department, Data Science & Innovation

■Job Description：

Translational Scientist is an expert in leading the science of drug development from diverse perspectives, including pharmacology, bioscience, biomarkers, precision medicine, and translational research.
Translational Scientist plays a key role in the following roles. He/she directly reports to the Translational Sciense Director.

• Lead the strategies for patient selection using the biomarker tests to deliver Companion Diagnostics (CDx) for drug development products (for applicable projects).

• Prepare Precision Medicine components in the regulatory documents and clinical trial-related documents, and handle the inquiries at regulatory events in Japan (for applicable project).

• Assess the preclinical pharmacology profiles of early development candidates to contribute to AZ's drug development program.
• Prepare the preclinical pharmacology components in regulatory documents and clinical trial-related documents, and handle the inquiries at regulatory events in Japan.
• Provide scientific support to the team to ensure smooth implementation of Japan development program.
• Leads collaborative research initiatives in scientific area with external partners in Japan to enrich AZ's portfolio (for applicable projects with opportunities).

■Experience：

＜必須＞

• Experience of clinical development of Oncology products with Precision Medicine concept.

• Experience in drug development using knowledge as a scientist in fields such as pharmacology, bioscience, biology, and life medicine/science.
• Experience in regulatory interaction with health authorities and CTD preparation.
• Well-versed in the drug/CDx development process and relevant regulatory guidance/guidelines, including ICH guideline, within the Japanese pharmaceutical industry.

• Experience in planning and implementing preclinical studies and/or translational research in the pharmaceutical industry.

＜歓迎＞
• Experience in planning scientific strategies as a expert with at the cross-functional team.

■License：

＜必須＞

• Bachelor's degree in Life Science related

＜歓迎＞

• Master's degree or PhD in relevant discipline 

■Skill Set：

＜必須＞

• Assertive communication skill
• Logical thinking skill
• Writing skill in Life Science area
• Presentation skill
• Business English
＜歓迎＞

• Strategic influencing skill
• Negotiation skill
• Conceptual thinking skill
• Leadership capability

■Languages：

• Read/write scientific documents including data interpretation in English/Japanese
• Communicate, and discuss the relevant-topics with the key stakeholders and experts in English/Japanese practically
• Make a English/Japanese presentation

■Career Level：

D

■Location：

大阪 or 東京