工作职责: 1. Act as clinical pharmacology lead on multidisciplinary teams working closely with clinicians, biostatisticians, clinical operations, regulatory, pharmacology and toxicology colleagues to design, conduct and report clinpharm/pharmacometrics/bioanalysis components in clinical studies. 2. Conduct non-compartmental and essential pharmacometrics analysis to support key program decision-making. 3. Responsible for study design and data interpretation for dedicated clinical pharmacology studies, including pharmacokinetics, pharmacodynamics, food effect, relative bioavailability, drug-drug interaction, QTc, ethnic PK bridging and special population studies, et al. 4. Author clinical and regulatory documents related to clinical pharmacology components, including protocols, investigator brochures, study reports, briefing documents for IND, regulatory meetings, and NDA/BLA, et al. 5. Provide oversight and work closely with collaborators and CROs related to Clinpharm/Pharmacometrics/Bioanalysis. 6. Perform other duties as assigned.
任职资格: 1· 3 years experience of PK/PD modeling and simulation with Master's or PhD degree in relevant disciplines such as pharmaceutical sciences, pharmacometrics, mathematics, statistics, biostatistics, 2· In-depth understanding of pharmacokinetic and pharmacodynamic principles 。 3· Hands-on experience of common tools for modeling and simulation tools, such as NONMEM, R, Phoenix, PKsim. 4· Proficiency in communication and presentation skills