Job Responsibilities will include but not limit the followings. As the Toxicology in-house expert, support programs to enable vaccine candidates from discovery through development. Design, place, and monitor preclinical toxicity studies and finalize associated reports for chemical and biological projects that will allow the clinical trials and/or worldwide registration file submissions. The work contracted-out in GLP laboratories should be performed in compliance with the national and international guidelines (e.g. CFDA/EMEA/CBER/ICH/WHO) and good laboratory practices (GLP, OECD, ICH). Design non-GLP investigative and toxicology studies to support development drug, as needed. Review, summarize and integrate complex data sets across multiple disciplines. Interact cross functionally with Research, Regulatory, Clinical and Manufacturing. Work closely with clinical to ensure toxicology support for clinical trial designs. Provide input and support on the preparation of regulatory documents (CTD, IND, CTA, PSUR/DSUR, Q&A, etc.) needed during drug development. Ensure high scientific and regulatory standards of non-clinical toxicology and safety documents submitted to regulatory authorities worldwide. Maintain extensive scientific awareness and presence internally and externally, publish manuscripts and posters, present at scientific conferences and other scientific forums, engage with consultants and advisors in the field, as well as the scientific community at large. Serve as a tox/safety expert to evaluate the projects from potential external partners to identify in-license opportunity. Help CMC department to set reasonable limit for impurities, OEL, and PDE from toxicology angle.
职位要求:
Master’s Degree in toxicology, pharmacology, or a closely related field of study, with 5+ years of industry experience covering different areas of toxicology for drugs and biologic Expertise in toxicology, PK and pharmacology, including guidelines, requirements and regulations, methodologies, and results interpretation & presentation. Experience with regulatory guidelines, legislation, registration procedures, and regulatory authorities both in China and Global. Experience working with Contract Research Organizations. Excellent verbal and written communicator with bilingual (English and Chinese) Preferred Qualifications PhD and Board certification in Toxicology, Laboratory Animal Sciences, or a related discipline American Board of Toxicology (DABT) or other recognized Toxicology certification Knowledge of related disciplines (chemistry, biology, drug metabolism/pharmacokinetics, safety and clinical study design) to enable multidisciplinary approaches