工作职责:
1.非临床药代动力学、毒理学试验设计、监管、方案和报告审阅、数据分析。
Responsible for the design, supervision, protocol, report review and data analysis of nonclinical pharmacokinetics and toxicological studies for discovery and development projects.
2.选择、评估完成非临床研究的外包合作公司并与外包合作单位密切合作按照要求完成有关项目。
Select and evaluate CROs for non-clinical studies, and work collaboratively with external partners to complete projects as required.
3.撰写新药申报文件M2.4、2.6、IB并与国内外监管部门沟通新药申报有关的非临床问题。
Write M2.4, 2.6, IB and communicate with domestic and foreign regulatory authorities on non-clinical issues related to new drug application.
4.与内外部单位合作，进行新药项目引进或者卖出的非临床资料审阅与评价，并根据数据提出科学建议、处理和解决有关问题
Review and evaluate the non-clinical documents of license-in or license-out of new drugs in partnership with external organizations, make scientific suggestions to deal with and solve related problems according to the data.
任职资格:
1.生物学、生物技术、药理学、药代动力学、毒理学或医学相关专业硕士或者博士。
Master or PhD in biology, biotechnology, pharmacology, pharmacokinetics, toxicology, or medical related science.
2.具有生物药、小分子和/或ADC等非临床药代、毒理研究工作经验者优先考虑。
Experience in non-clinical pharmacokinetics, toxicological studies of biological drugs, small molecules, and/or ADCs is preferred.
3.熟悉新药研发的相关法律法规和指导原则，包括但不限于GLP、ICH指导原则。
Strong knowledge of relevant laws and regulations and guidelines of new drug development, including but not limited to GLP and ICH guidelines.
4.具有良好的中英文写作能力和沟通协调能力以及团队合作精神。
Good English and Chinese writing skills. Good communication skills and team work spirit.
5.积极主动、高效灵活的工作态度，以结果目的为导向、能适应快速变化的工作环境。
Proactive, efficient and flexible working attitude, results-oriented, and capable of adapting to a fast-changing work environment.