Pre-clinical Director
岗位职责• Assist the department head in planning and establishing preclinical trials of projects within the department, prepare relevant budgets, and promote project progress;
• Collect and evaluate qualified external CROs, plan the cooperation between internal and external CROs as a whole, and complete the promotion of preclinical trials;
• Assist each project team in the department in the pre clinical work required, provide professional suggestions, propose pharmacodynamic or toxicological related plans after collecting literature, from pre clinical models to implementation methods, plan review, and promote the project forward;
• Be responsible for the overall management of animal room and cell room laboratories;
• Pre clinical data sorting, reporting, tracking system establishment and relevant document management system establishment;
• Cooperate with the need to complete the pre clinical application data of the project.
Qualification
• Master degree or above in pharmacy or other related majors, more than 3 years of experience in preclinical evaluation of new drugs, and experience in applying for a complete IND is preferred;
• Be familiar with the evaluation methods related to the pharmacology of new drugs, and be able to independently take charge of the pre clinical evaluation of new drugs in cooperation with CRO;
• Be familiar with the laws and regulations related to drug registration, and be able to complete the writing of new drug materials and relevant review materials;
• Have good communication ability and cooperation spirit, strong sense of responsibility, and project management experience is preferred;
• CET 6 or above is required, and PPT, Word, Excel, SPSS, Prism and other working software are required.