Study Dir /Sr. Study Dir in Exploratory Toxicology -毒理

工作地点：上海浦东         所属类型：DMPK         发布时间：2019-01-08

岗位描述：

Responsibility

The Study Director or Senior Study Director of Toxicology is responsible for all aspects of the exploratory toxicology studies in rodents and large animals conducted at the test facility or partner facilities. Duties include, but are not limited to the following:

• Design and execute nonclinical toxicology study protocols, IACUC submissions; analyze and interpret the results, and write a final report of the study

• Monitor all aspects of a study, and assure study protocols, SOPs, and related regulatory compliance and animal welfare standards for studies, and on-time delivery of high quality reports at the completion of each study.

• Provide leadership, technical support, expertise for preclinical study design, analysis of data, and interpretation of results for all of the toxicity studies as necessary

• Provide the training to toxicology technical staff as required

• Remain current on appropriate company SOPs, good laboratory and documentary practice, and regulatory guidelines.

任职资格：

Qualification

• A M.S.(8 years and above), or Ph.D. degree(5years and above) in toxicology or related fields (pharmacology, medicine, veterinary medicine, physiology, etc.) with 5- 10 years’ experience in pharmaceutical and biotechnological companies, or contract research organizations.

• Board Certification in Toxicology (Diplomate, American Board of Toxicology (DABT), or others) is desirable.

• Hands-on experience in planning, designing, conducting, monitoring and interpreting nonclinical toxicology studies such as MTD (maximum toleration dose) and DRF (dose ranging finding) studies in mice, rats, dogs and monkeys in drug discovery and preclinical development is required.

• Knowledge of the general principles of toxicology, animal and human biology and physiology, especially clinical and functional changes associated with toxicity Knowledge of laboratory animal welfare standards (AAALAC, etc.)

• Knowledge of Good Laboratory Practice (GLP) and relevant FDA, ICH and other regulatory guidelines is essential.

• Detail orientation, excellent written and oral communication skills in English and Chinese, Good interpersonal communication and effective leadership skills