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: 学历及专业: Minimum of 1year (Ph.D) or 3 year (Master) of new drug development experience working as a clinical pharmacologist, DMPK or pharmacometrician within pharmaceutical industry. 博士1年以上或硕士3年临床药理学,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。