临床药理高级研究员/经理(J30420)

主要职能

1. 01

   Responsible for the clinical pharmacology plan, design and assessment. 负责药物的临床药理规划， 设计和评价。

2. 02

   Responsible for the key clinical pharmacology input, including clinical pharmacology bridge, new drug dose selection. 解决临床药理学桥接、 创新药给药方案设计等关键技术问题。

3. 03

   Keep good connection with PI, KOL. 与行业专家保持良好的联系。

4. 04

   Participate in HA meeting and discussion. 参加监管沟通会议和讨论。 5 ) Team, platform，SOP/WI/Template construction and management 团队， 平台， SOP/WI/模板建设和管理。 主要职责和任务： Responsible for： 负责：

5. 01

   analyze pre-clinical PK/I>D/safety/efficacy data and do human prediction. 解析临床前PK/PO/安全性/有效性数据， 进行人体预测。

6. 02

   do FIH dose escalation design, PK/PD design. 设计首次人体剂量爬坡和PK/PD。

7. 03

   do clinical PK/PD/safcty/cfficacy 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。

8. 04

   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： 临床研宄方案、 监管会议材料、 NCA PK报告、 PopPK/PD报靑、 E-R报告、NDA/BLA材料。

9. 05

   Team，platform, SOP/WI/'iemplate construction 团队，平台，SOP/WI/模板建设。

10. 06

    Participate in HA meeting and discussion. 参加监管沟通会议和讨论。 7 ) Keep good connection with PL KOL. 与行业专家保持良好的联系。

1. 01

   Senior Scientist I/II, Associate Manager, Manager, 高级研究员I/II, 副经理，经理 Minimum of 1 year (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领域新药幵发经验。 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幵发决策的成功经验。 精通 Monolix/NONMEM, PKanalix/WinNonlin,R. Knowledge of health authority perspective on clinical pharmacology. 全面的临床药理学监管知识体系。 Good verbal and wrilten communication skills in English. 优秀的英文表达和写作能力。 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。