BSc with a PhD degree preferred in Pharmacology, Pharmaceutics, or related disciplines (or equivalent degree/knowledge/expertise)
- Fluent in written and spoken English
- Broad background and a comprehensive understanding of Clinical Pharacology aspects of drug development
- Pharmaceutical R&D experience
- Expert knowledge of pharmacokinetics and its clinical application
Thorough understanding of early and late clinical programs in Clinical Pharmacology, including M&S
At least 5 years of experience in clinical pharmacology in multi-national pharmaceutical industry
Experience in the use of WinNonlin, NONMEM, R or S-plus, database management, or related scientific software
DUTIES & RESPONSIBILITES
- Responsible for designing and developing clinical pharmacology programs (both small and large mocecules) for supporting China regulatory submissions and approvals
- Responsible for protocol preparation, data review and analysis, and study reports for China PK studies across all disease areas.
- Responsible for providing Clin Pharm contributions to phase 3 study and China regulatory documents and other documents in accordance with general standards, guidelines, and processes
- Deliver high-quality evaluation and interpretation of clinical pharmacology data (pharmacokinetics, pharmacodynamics, safety, dose/concentration response).
- Interact with investigators with regard to scientific issues.
- Serve as a China liaison with Global Clinical Pharmacologist for the assigned projects.
Serves as core member of the China Project Team, where appropiate, for all clinical PK and PK/PD aspects of development projects and programs.
Responsible for delivering quantitative pharmacology and modeling & simulation supports to clinical development projects
- Assist in evaluation of in-licensing opportunities for clinical PK and PK/PD components
Contributes to the identification, characterization, and validation of potential biomarkers and/or surrogate markers and measurements in non-clinical and clinical studies
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.