Principal/Assoiciate Director, Pharmacology
Key Tasks
- Responsible for designing and developing clinical pharmacology programs (both small and large mocecules) for supporting R&D 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
Academic / Professional Qualification
- BSc with a PhD degree preferred in Pharmacology, Pharmaceutics, or related disciplines (or equivalent degree/knowledge/expertise)
Technical / Skills Training
- Fluent in written and spoken English
- Broad background and a comprehensive understanding of Clinical Pharmacology 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
Working Experience
- 5-8 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
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.
阿斯利康是一家提供平等机会的企业，我们将考虑所有符合条件的求职者就业。不因残疾、性别或性取向、怀孕或产假状况、种族或民族或族裔出身、年龄、宗教或信仰、性别认同或变更、婚姻或伴侣关系、受保护的退伍军人身份（如果适用）及任何其他受法律保护的特征而产生歧视。
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.
