深圳市泰华细胞工程有限公司
临床项目经理
Skills
1 year ago
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Important information
Contract type:
Permanent
Location:
Xi'An, Shaanxi, China
Work mode:
Onsite
Published on:
7 August 2026
What they need
该职位来源于猎聘 岗位职责: 1、全流程管理 CAR-T 临床项目(I-III 期),把控方案设计、中心启动、受试者入组及数据交付; 2、确保项目符合 GCP 及细胞治疗法规,重点管控 CRS/ICANS 等特发性不良反应; 3、协调临床中心、CRO 及内部研发 / 生产团队,保障项目进度与质量; 4、支撑 IND/NDA 申报,主导风险评估与 CAPA 落地。 任职要求: 1、硕士以上学历,临床医学 / 免疫学 / 生物制药相关专业; 2、5 年以上临床项目管理,2 年 + CAR-T / 基因治疗项目主导经验,有 IND 申报经历优先; 3、精通细胞治疗临床法规(NMPA/FDA)及 GCP,持 GCP 证书者优先; 4、具备跨部门资源整合与团队管理能力; 5、公司自研项目,可接受出差。
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