温州长江汽车电子有限公司
DMPK(高级)经理(J10102)
2 months ago
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Important information
Contract type:
Permanent
Location:
Shanghai, China
Work mode:
Onsite
Published on:
11 September 2026
What they need
该职位来源于猎聘 职责描述: 1) 评价小分子药物体外ADME、体内药代动力学、毒代动力学试验的特征; 2) 负责药代/毒代实验设计、分析方法开发、数据处理和展示; 3) 负责解决研究过程中出现的问题,确保数据质量可靠; 4) 撰写、审核小分子药物药代相关的申报资料,配合完成申报工作; 5) 考察药代CRO的资质,确定选择CRO服务机构,与CRO技术团队沟通,跟踪试验进度,监督CRO研究质量和审核研究数据,总结和解读试验结果。 6) 与相关部门及BD、PM、RA密切合作关系,提供技术支持; 7)
领导交代的其他任务 任职要求: 1) 硕士以上学历,药代动力学、分析化学相关专业,5年以上新药研发经验; 2) 具备体外和体内PK研究的实践经验,熟悉临床前药代动力学研究及NMPA/FDA有关小分子药的指导原则; 3) 具有良好的中、英文写作及口语能力,善于检索阅读文献、设计实验方案、分析并展示实验数据; 4) 具有良好的解决问题能力,沟通能力以及团队合作精神,具备良好的职业素养及创新能力; 5) 有小分子药物NDA申报经验者优先。
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