陕西麦科奥特科技有限公司
定量药理经理
Skills
3 months ago
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Important information
Contract type:
Permanent
Location:
Beijing, China
Work mode:
Onsite
Published on:
9 August 2026
What they need
该职位来源于猎聘 1、建立并执行PopPK模型，评估个体间/个体内变异，识别影响暴露量的协变量；
2、建立暴露-反应（E-R）模型，量化药物暴露量与疗效终点及安全性终点之间的关系，支持有效性和安全性的风险评估；
3、建立疾病进展模型，评估药物对疾病病程的长期影响，以优化确证性临床试验的持续时间； 4、利用生理药代动力学模型或PopPK模型，预测儿科、肝/肾功能不全、老年人群的合适起始剂量和维持剂量； 5、撰写NDA/IND/BLA申报资料中的临床药理部分，撰写PopPK、E-R分析等专项报告； 6、准备与监管机构沟通的会议资料，回答CDE、FDA或EMA关于剂量选择、临床药理策略的审评问题
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