• 招聘类型：社招
• 工作性质：全职

职位描述

• To propose safety and non-clinical strategies to support non-clinical development of drug candidates successfully IND/NDA filing.
• Define study requirements and coordinate appropriate non-GLP and GLP Tox in non-clinical project development in accordance with the Health Authorities requirement; contribute to the design of non-clinical study; identify potential project hurdles and suggest solutions.
• Contribute expert input into regulatory documents including investigator brochures, clinical study protocols and Development Safety Update Report within agreed timelines; Prepare, compile, and review appropriate sections of registration documents; represent Non-clinical in interactions with health authorities and external partners.
• To coordinate cross-functional effort in planning budgets, timelines and resource allocations.
• To monitor timelines and objectives, ensure accuracy of project and activity progress, assure rapid and effective communication of high-quality data and results to project teams.
• To participate in and contribute to the feasibility assessment of proposed new projects and ventures during the project evaluation process.
• Performs other related duties as assigned.

任职条件

• Master of pharmacology degree or above in biochemistry, biology, DMPK preferably pharmacology and toxicology, 5 years+ of experience in pharmaceutical industry
• Previous experience in new drug development
• In-depth knowledge of non-clinical toxicology (in vitro and in vivo), SOP, guidelines and GLP principles is must
• Fluent in oral English and effective communication
• Strategic thinking and good planning skills
• Performance driven
• Self-motivated and able to motivate the team

职位要求

• 学历要求：无
• 工作经验：无
• 外语要求：不需要