Website Kanghong Pharmaceutical
Toxicologist (Associate Director/, D/S Director)
Main Job responsibilities
The primary responsibility of this position is to provide strategic preclinical safety expertise and representation for nonclinical and clinical development programs from IND enabling through post-marketing.
1、Extensive experience applying in-depth theoretical knowledge with a sustained track record of applying problem solving skills to move projects forward.
2、Extensive understanding of toxicology, pharmacology, DMPK and management science, providing necessary toxicological research for clinical development of biologics and small molecule drugs.
3、Project leader for multiple pre-clinical safety research projects, ensure the completion of project goals and deliverable.
4、Ensure that the pre-clinical safety research program meets the requirements of the clinical development plan and current regulations (such as FDA, GLP etc.).
5、Serve as a tox/safety research expert within their field of sub-specialization to provide input on other programs and studies, including external partnerships.
6、Collaborate with other functional groups internally or externally (study management, clinical, regulatory, research, translational sciences, DMPK, CMC, etc.) on program-related tasks and objectives.
7、Prepare high quality nonclinical regulatory documents to support regulatory submissions and clinical development is a plus.
1、More than 5 years of toxicological research, drug research and management experience in biotechnology, pharmaceutical industry or CRO industry.
2、Demonstrated experience and expertise with both GLP and non-GLP compliant in vitro and in vivo toxicology study conduct and reporting.
3、A high degree of familiarity with applicable regulatory guidelines (ICH, FDA, GLP, etc.) and prior experience with regulatory agency interactions is preferred.
4、Demonstrating good leadership, organization and management skills, able to communicate effectively with partners and internal and external experts on toxicology research.
5、Must possess good communication and technical writing skills in English. Capable of engaging in scientific dialog among large groups of scientists, senior management, and external scientific experts.
6、Experience in Ophthalmology or CNS area is plus.
7、PhD in toxicology or related fields,Toxicology board certification is a plus.