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.

Requirements

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

Career Level : E

Date Posted

Closing Date

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.