(高级)临床药理研究员 II / I

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:

学历及专业：

Minimum of 1year (Ph.D) of new drug development experience working as a clinical pharmacologist, DMPK or pharmacometrician within pharmaceutical industry.

应届博士或1年以上临床药理学，定量药理学或DMPK领域新药开发经验。

专业知识：

(1) Successful experience developing advanced pharmacometirc approach to aid in research and development decision making.

应用定量药理学技术辅助药物开发决策的成功经验。精通Monolix/NONMEM, PKanalix/WinNonlin, R。

(2) Knowledge of health authority perspective on clinical pharmacology.

全面的临床药理学监管知识体系。

技能要求：Good verbal and written communication skills in English.

英语六级，优秀的英文表达和写作能力。

其他要求：Demonstrated ability to work in a highly collaborative and result-directed setting.

经验证的协作能力和结果导向。