岗位职责：

1、负责非临床药代动力学研究方案设计，组织实施试验开展，统筹协调内外部资源，确保项目按计划推进，对整个试验设计和实施过程的科学性负责；

2、负责撰写、审阅、修订试验方案、数据、报告、IND/NDA申报资料及相关SOP等中、英文文件，确保研究的资料真实、准确、有效以及SOP文件的适用性；

3、支持与国内、外客户及专家的技术与商务交流；

4、负责前沿技术内容与文献调研、跟踪监管环境的变化、国内外相关指导原则的更新，支持内部业务能力的优化提升；

5、完成上级领导安排的其他工作。

任职要求：

1、硕士及以上学历，药学、医学、生物学相关专业，掌握药物化学、药物分析学、生物化学等学科的基本知识；拥有5年以上非临床药代动力学研究经历，具备丰富的国外客户项目交付和技术交流经验，曾在海外CRO公司任职者优先；

2、熟悉NMPA/FDA/EMA等相关药代动力学研究指南与法规；

3、具有较强的文献调研及汇总能力，有熟练的英语听说读写能力，口语流利，能够无障碍地进行跨国会议、技术研讨和书面报告；

4、具备较强的学习与整合能力、沟通协调能力、团队合作精神及责任心。

Duties & Responsibilities:
·Responsible for designing preclinical pharmacokinetic study protocols, organizing and implementing experiments, coordinating internal and external resources, ensuring projects proceed as planned, and taking responsibility for the scientific validity of the entire study design and implementation process.
·Responsible for writing, reviewing, and revising study protocols, data, reports, IND/NDA application materials, and relevant SOPs (both in Chinese and English), ensuring the authenticity, accuracy, and validity of research materials as well as the applicability of SOP documents.
·Support technical and business communications with domestic and international clients and experts.
·Responsible for researching cutting - edge technologies and literature, tracking changes in the regulatory environment, and updates to relevant domestic and international guidelines to support the optimization and improvement of internal business capabilities.
Experience Requirements - Knowledge, Skills, & Abilities (KSAs):
·Master's degree or above in Pharmacy, Medicine, Biology or related disciplines, with a good command of basic knowledge in Pharmaceutical Chemistry, Pharmaceutical Analysis, Biochemistry and other subjects.
·At least 5 years of experience in non-clinical pharmacokinetics research, rich experience in overseas client project delivery and technical communication, and prior work experience in overseas CRO companies is preferred.
·Familiar with NMPA/FDA/EMA and other relevant pharmacokinetics research guidelines and regulations.
·Strong ability in literature research and summarization.
·Excellent written and oral communication skills in English as a must, conduct cross-border meetings, technical discussions and written reports without obstacles.
·Strong learning and integration abilities, communication and coordination skills, teamwork spirit and sense of responsibility.