メディカル・バイオ - 前臨床（薬効薬理・毒性・ADME）

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.

■休日：完全週休二日制, 年末年始

■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

■職種未経験者：不可