工作职责:
岗位目的
1) Participate in the clinical pharmacology design and assessment.
参与药物的临床药理设计和评价。
2) Coordinate and communicate with internal team and external team.
团队内部、外部的协调和沟通。
3) Responsible for data organization, analysis and document preparation.
负责研究数据的整理、分析和相关文档的准备。

主要工作职责
Assist clinical pharmacology project leader to：
协助临床药理学项目负责人：
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。
任职资格:
1) Fresh PhD, major in Pharmacokinetics/DMPK, pharmacometrics, clinical pharmacology, clinical pharmacy, etc.
应届生博士生，药代动力学/DMPK、定量药理学、临床药理学、临床药学，等相关专业（方向）。
2) Master with minimum of 1year of new drug development experience working as clinical pharmacologist, DMPK or pharmacometrician.
硕士，1年以上临床药理学，定量药理学或DMPK领域新药开发经验。