公司简介

"华东医药长在,生命之树常绿"
岗位职责:
Job Description:
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.
资历要求:
Qualification requirements:
1、硕士或博士,或同等学历
Master or PhD, or equivalent
2、至少5-10年直接的新药相关开发经验,工作主要集中于临床前研究和临床阶段的非临床研究。
At least 5-10 years of direct new drug-related development experience, focusing on preclinical studies and non-clinical studies in clinical stages.
3、在新药早期开发,临床前研究阶段和临床阶段的非临床研究部分具有丰富的实践经验。
In the early development of new drugs, the non-clinical research part of the preclinical research stage and clinical stage has rich practical experience.
4、在创新药项目方面拥有丰富的知识和经验,包括跨技术领域(CMC,药理,ADME,药代,毒理,临床前到临床转化等)和跨国的工作经验。
Extensive knowledge and experience in innovative drug projects, including cross-technical areas (CMC, pharmacology, ADME, pharmacokinetics, toxicology, preclinical to clinical transformation, etc.) and cross-country work experience.
5、必须具有强烈的工作紧迫感和责任感; 具有有效解决问题的能力; 良好人际关系/组织技能及英语沟通能力。
Must have a strong sense of work urgency and responsibility; Ability to solve problems effectively; Good interpersonal relationship / organizational skills and English communication skills.
The specific rank is determined by the experience after the interview.