【AstraZeneca】【R&D】Clinical Pharmacology Scientist/Pharmacometrician, Clinical Pharmacology & Safety sciense Department, Data Science & Innovation

■ 職務内容 / Job Description

Clinical Pharmacology Scientist/Pharmacometrician is one of key roles for clinical development programs and new drug applications (NDA) mainly in Japan.  Therefre, he/she surely plays the following roles.  He/she directly reports to the Clinical Pharmacology & Safety Sciense Director.

1. Responsible for initial assessment of preclinical and clinical pharmacokinetic profiles of new candidates, and supports clinical options and strategies on Japan development program based on the profiles
2. Supports pharmacokinetic and pharmacodynamic components in clinical studies which AZKK implements
3. Leads the authoring on ADME & preclinical pharmacokinetics (DMPK) and clinical pharmacology (CP) components in regulatory documents, and responsible for DMPK/CP inquiries at regulatory events in Japan
4. Responsible for Japan specific requirements on global DMPK/CP package
5. Supports the package inserts and interview form
6. Responsible for giving clear instructions to Career Level C staff on his/her task, and supports Career Level C/D staff on critical decisions on development strategy and regulatory interaction and accountable for the outputs
7. Leads research collaborations on DMPK/CP area with academia and biotech/Pharmaceutical companies in Japan
8. Responsible for PMx components in the regulatory documents (only Pharmacometrician)
9. Leads planning, implementing and reporting PMx analyses on demand (only Pharmacometrician)

■ 応募資格（経験、資格等）/ Qualification (Experience & Skill etc.)

【経験 / Experience】

＜必須 / Mandatory＞

1. Experience of JNDA submission including CTD preparation
2. Experience of regulatory interaction such as authority consultation, query response
3. Well knowledge of preclinical DMPK studies including in vitro test using animals and human materials

＜歓迎 / Nice to have＞

• Experience of clinical development of new modalities such as oligonucleotide therapeutics and cell therapeutics
• Experience of electronic data submission

【資格 / License】

＜必須 / Mandatory＞

• Master degree (speciality: clinical pharmacology, pharmacokinetics or pharmacometrics)

＜歓迎 / Nice to have＞

PhD (speciality: clinical pharmacology, pharmacokinetics, or pharmacometrics)

【能力 / Skill-set】

＜必須 / Mandatory＞

1. Well-known the requiredments in ADME and clinical pharmacology areas
2. Well-versed in Japan guidelines related to CP, PK and ADME

[Only for pharmacometrician]
Programing skills such as NONMEM, R, Python, etc.

＜歓迎 / Nice to have＞

• Have a good knowledge about new modalities

【語学 / Language】

＜必須 / Mandatory＞

日本語 Japanese：
• Read/write scientific documents including data speculation in English/Japanese
• Communicate, and discuss CP/DMPK topics with the key stakeholders and experts in English/Japanese practically
• Make a Japanese presentation

英語 English：
• Read/write scientific documents including data speculation in English/Japanese
• Communicate, and discuss CP/DMPK topics with the key stakeholders and experts in English/Japanese practically
• Make a English presentation

【キャリアレベル / Career Level】

E

【勤務地 / Work Location】

Osaka / 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.