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临床药理高级经理/副总监

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临床药理高级经理/副总监

上海凯莱英生物技术有限公司

临床药理高级经理/副总监

Skills

R

2 months ago

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Important information


Contract type:

Permanent

Location:

Shanghai, China

Work mode:

Onsite

Published on:

31 August 2026

What they need


该职位来源于猎聘 岗位职责: 1.分析、解读并报告临床研究中的PK/PD数据和文献,合理设计新药早期临床方案中临床药理相关内容; 2.进行早期临床(包括人体试验,I期临床)试验设计,临床试验的方案的临床药理内容设计与撰写; 3.负责临床药理(如MB试验设计,DDI试验设计)及定量药理(如PPK/PD建模,E-R分析)相关研究和分析,并支持临床开发各阶段策略制定; 4.负责撰写和审阅临床药理相关文件; 5.负责临床药理相关问题的沟通; 6.负责临床试验设计相关流程及SOP撰写。 任职要求: 1.学历背景 :硕士及以上,药理学、临床药理学,药代动力学,临床药学等专业; 2.工作经验:有临床试验、临床药理相关工作经验; 3.能力要求:熟练使用办公软件、winnonlin、英语六级及以上,可进行FDA申报文件撰写; 4. 较强的逻辑思维能力,注重细节及质量、责任心、沟通能力、执行能力、团队与合作精神。

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