Pre-Clinical VP (China/US)
Job Title: Pre-Clinical VP
Report to: CMO
- Design and execute preclinical studies to understand the pharmacokinetics (PK) and absorption, metabolism, distribution, and excretion (ADME) of drug candidates.
- Manage CROs/Academic sites in the conduct of in vitro and in vivo ADME studies.
- Responsible for the analysis, interpretation, integration, and reporting of preclinical DMPK data generated with CROs; Lead efforts for IND and NDA/BLA filings.
- Work closely with business development group to evaluate external opportunities.
- Build close relationships with partner functions and therapeutic areas.
- Evaluate and implement novel technologies to characterize the disposition and clearance mechanisms of new chemical entities.
- Ph.D. in Pharmacokinetics, Pharmacology, Pharmaceutics or other relevant field with over 10 years of experience in biopharmaceutical industry, with evidence of drug development experience is preferred.ß
- Strong knowledge of drug metabolism, ADME concepts, PK, PD and bioanalytical principles is required.
- Experience working with CROs to deliver on radiolabeling ADME studies, including rat QWBA, human ADME, and metabolite ID experiments
- Experience working through IND to NDA package submission, Oncology project preferred.
- Excellent oral and written English.