工作职责:
1) Analyze pre-clinical PK/PD/safety/efficacy data and do human prediction.
解析临床前PK/PD/安全性/有效性数据，进行人体预测。
2) Do FIH dose escalation design, PK/PD design.
设计首次人体剂量爬坡和PK/PD。
3) Do clinical PK/PD/safety/efficacy analysis, and recommend dose regimen.
开展临床PK/PD/安全性/有效性分析，推荐给药方案。
4) Writing clinical pharmacology documents, including clinical study protocol, HA meeting documents, NCA PK report, Pop PK/PD report, E-R report, NDA/BLA package.
撰写临床药理材料，包括：临床研究方案、监管会议材料、NCA PK报告、Pop PK/PD报告、E-R报告、NDA/BLA材料。
5） Team, platform, SOP/WI/Template construction
团队，平台，SOP/WI/模板建设。
6） Participate in HA meeting and discussion.
参加监管沟通会议和讨论。
7) Keep good connection with PI, KOL.
与行业专家保持良好的联系。
任职资格:
Minimum of 5year (Ph. D) or 8 year (Master) of new drug development experience working as a clinical pharmacologist, DMPK or pharmacometrician within pharmaceutical industry.
博士8年以上临床药理学，定量药理学或DMPK领域新药开发经验。

(1) Successful experience developing advanced pharmacometirc approach to aid in research and development decision making and drug approval. Proficiency in Monolix/NONMEM, PKanalix/WinNonlin, R is a must.
应用定量药理学技术辅助药物开发决策和成功上市的成功经验。精通Monolix/NONMEM, PKanalix/WinNonlin, R。
(2) Knowledge of health authority perspective on clinical pharmacology. Successful experience health authority interaction is a plus.
全面的临床药理学监管知识体系和监管互动的成功经验