陕西麦科奥特科技有限公司
非临床药理总监
2 months ago
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Important information
Contract type:
Permanent
Location:
Xi'An, Shaanxi, China
Work mode:
Onsite
Published on:
14 August 2026
What they need
该职位来源于猎聘 1、根据公司管线(小分子、大分子、多肽等)特点,制定非临床研发策略;
2、评估项目的成药性风险,从非临床角度参与项目立项(Go/No-Go)决策; 3、负责创新药的体外、体内药效模型的选择与建立; 4、设计并监督药效学评价实验,验证药物的作用机制(MOA)及有效性; 5、负责与外部CRO(合同研究组织)对接,筛选CRO、审核试验方案、监督试验进度与质量,审核最终报告; 6、主导撰写非临床部分的申报资料; 7、确保非临床数据符合NMPA(中国)、FDA(美国)、EMA(欧洲)等监管机构的要求; 8、跟踪国内外GLP(药物非临床研究质量管理规范)及非临床研究的最新法规动态,及时调整研发策略。
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