【1100～1600万円】【R D】Clinical Pharmacology （CP） Scientist Clinica…

【求人No NJB2270876】
Job Description
・ Contribute to regulatory events in Japan such as CTN PMDA consultation and JNDA
・ Contribute to Drug Metabolism and Pharmacokinetics （DMPK） and CP sections in the regulatory documents such as JCTD and JIB
・ Check the future submission package of DMPK and CP areas
・ Contribute to clinical studies AZKK implements e.g. inputting CP sections in CSP and CSR designing pharmacokinetic （PK） and pharmacodynamic （PD） assessments in clinical study
・ Propose potential strategies based on DMPK/CP profiles at JPT
・ Negotiate with PMDA on Japan development strategy and JNDA package

Accountability/Responsibility:
・ Responsible for initial assessment of DMPK/CP profiles of new candidates
・ Supports clinical options and strategies on Japan development program based on DMPK and CP profiles
・ Supports PK and PD components in clinical studies AZKK implements
・ Leads the CP/DMPK authoring in regulatory documents
・ Responsible for DMPK/CP inquiries at regulatory events in Japan
・ Responsible for Japan specific requirements on global DMPK/CP package including CTD
・ Supports the package inserts and interview form
・ Responsible for giving clear instructions to Career Level C staff on his/her task
・ Supports Career Level D staff on critical decisions on development strategy and regulatory interaction and accountable for the outputs
・ Leads research collaborations on CP/DMPK with academia and biotech/Pharmaceutical companies in Japan

Clinical Pharmacology Scientist directly reports to the Clinical Pharmacology Safety Science Director.

■経験 Experience
必須 Mandatory
1. Experience of regulatory interaction such as authority consultation query response
2. Experience of JNDA submission including CTD preparation
3. Having biopharmaceutical knowledge （e.g. IVIVC） and being familiar with bioanalytical regulations.

歓迎 Nice to have
・ Experience of clinical development of new modalities such as oligonucleotide therapeutics and cell therapeutics
・ Experience of biopharmaceutical modelling （e.g. Gastro+）

■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 requirements 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 Languages
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

歓迎 Nice to have
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