华东医药股份有限公司 

临床前药理毒理经理/副总监

薪资面议  /  杭州

2023-02-28 更新

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职位属性

  • 招聘类型:社招
  • 工作性质:全职

职位描述

1、负责管理临床前研究团队,维护、协调与各CRO机构和其他合作伙伴的关系,与CFDA、CDE等相关部门及业内专家保持良好沟通,确保整个临床前研究项目按照计划有序快速地进行。

 

Responsible for managing preclinical research teams, maintaining and coordinating relationships with CROs and other partners, and maintaining good communication with CFDA, CDE and other relevant departments and industry experts to ensure that the entire preclinical research project is carried out in an orderly and rapid manner.

 

 

 

2、根据法规要求组织开展创新药临床前安全性评价研究,并承担申报资料审核工作。

 

Organize the preclinical safety evaluation of innovative drugs according to the requirements of the regulations, and undertake the review of the application materials.

 

 

 

3、配合创新药早期开发团队,组织开展创新药成药性早期评价研究工作。

 

Cooperate with the early development team of innovative drugs to organize research and development of early evaluation of innovative medicines.

 

 

 

4、配合临床团队,组织开展创新药临床阶段的非临床研究。

 

Cooperate with the clinical team to organize non-clinical research in the clinical stage of innovative drugs.

 

 

 

5、协调各项研究的实验进度,及时发现、解决问题并制定应急计划,以保证项目最终顺利进行。

 

Coordinate the experimental progress of each research, discover, solve problems and formulate contingency plans in time to ensure the smooth progress of the project.

任职条件

1、At least 5-10 years direct relevant experience in new drug development, focus on pharmacology, toxicology and DMPK.

 

2、Hands on experience new drug early development, IND enabling stages, and nonclinical part of clinical stages.

 

3、Extensive knowledge and experience in scientific project management, including working across functions (CMC, pharmacology, ADME, PK, Tox, translation from preclinical to clinical…) and countries.

 

4、Strong sense of urgency and responsibility must; capability to effectively solve the problems.

 

5、Effective interpersonal/communication/organizational skills, including English communication skills.

 

6、Education: Master or Ph.D , or equivalent relevant degrees or certificates.

公司福利

  • 成熟人才培养体系
  • 工资面议
  • 培训
  • 取暖费
  • 免费班车
  • 代薪休假
  • 餐饮补贴
  • 拓展、年会等
  • 住房补助
  • 出国机会
  • 专业培训
  • 弹性工作
  • 实物及卡
  • 节日福利
  • 通讯补贴
  • 特色员工活动
  • 五险一金
  • 人才培养体系
  • 旅游
  • 效益分红
  • 带薪年假
  • 绩效奖金
  • 租房补贴
  • 包中餐
  • 福利
  • 员工体检
  • 餐补
  • 防暑降温费
  • 法定节假日
  • 带薪年休
  • 高温补贴
  • 年休假
  • 定期体检
  • 交通补贴
  • 节日礼金
  • 年终奖金
  • 交通补助
  • 员工旅游
  • 过节费
  • 成熟培训体系