职责描述: Clinical pharmacology studies 40% - Responsible for designing an******** clinical pharmacology programs(both small an******** mocecules) for supporting China regulatorysubmissions an******** - Responsible for protocol preparat******** data review an********,an******** reports for China PK studies across all disease areas. - Responsible for providing Clin Pharm contributions to phase 1 study(China Innovation Medicine of Oncology 3759 & 9291) or phase 2/3study (Oncology/ CV/ Diabete******** Respiratory of small molecurean******** of large molecure), an******** regulatory documentsan******** documents in accordance with general stan******** gu********an******** - Deliver high-quality evaluation an******** of clinical pharmacologydata (pharmacok******** pharmaco******** safety, exposure response). - Interact with investigators with regar******** scientific issues.
Pharmacometrics 50% - Responsible for delivering quantitative pharmacology an******** &simulation supports to clinical development projects
Others 10% - Assist in evaluation of in-licensing opportunities for clinical PKan********/PD components - Contributes to the ******** character******** an******** of potentialbiomarkers and/or surrogate markers an******** in non-clinicalan******** studies
任职要求: • Minimum of a master degree in Pharmacology, Pharmaceut******** orrelate******** (or equivalent degree/knowledge/expertise) • Goo******** of Clinical Pharmacology, PK/PD modeling conceptsan******** statistics • Demonstrate******** in PK/PD modeling & simulation • Goo******** skills with the ability to multi-task an********assignments (planning an********) • Goo******** of clinical drug development • At least 4 years of experience in clinical pharmacology inmulti-national pharmaceutical industry Experience in the use of W******** NONMEM, R or SAS or S-plus, orrelate******** software.