【AstraZeneca】【R&D】Translational Scientist, Translational Sciense 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.
• 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.
• 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).
• Provide scientific support to the team to ensure smooth implementation of Japan development program.
• Leads collaborative research initiatives in sicentific area with external partners in Japan to enrich AZ's portfolio (for applicable projects with opportunities).
• Assist younger staffs in product related issue solving by coaching and encouraging.
■Experience:
<必須>
• Experience in drug development using knowledge as a scientist in fields such as pharmacology, bioscience, biology, and life medicine/science.
• Experience in planning and implementing preclinical studies and/or translational research in the pharmaceutical industry.
• 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.
<歓迎>
• Experience of clinical development of Oncology products with Precision Medicine concept.
• 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:
E
■Location:
大阪 or 東京