1、 Provide bioanalytical and assay expertise to enable pre-clinical pharmacologic assessments of novel small molecules, antibodies and biologics
2、Collaborate effectively with the research team to develop and execute pre-clinical assays and validate those for use in non-clinical and clinical studies
3、Develop interdisciplinary collaborations and ensure DMPK analyses, studies and priorities are integrated into overall project team strategy.
4、Work with external collaborators and service providers to support key project goals including quantitative systems pharmacology modelling to inform non-clinical and clinical studies
5、Responsible for the design and interpretation of DMPK assays, studies and technical report writing necessary for the selection of clinical candidates and for the filing of regulatory documents.
6、Contribute to candidate selection, development strategy, clinical trial design, clinical study protocols and execute and coordinate clinical trial conduct and finalize preclinical and clinical study reports.
7、 Participate in budgeting and due diligence activities.
1、Candidate should have a Ph.D. or equivalent in a relevant scientific discipline, pharmacology or pharmaceutical sciences with 8+ years of experience in DMPK roles
2、Experience with writing of technical reports in support of regulatory filings
3、Strong understanding of guidance from regulatory agencies on DMPK assay development and qualification
4、 Experience in managing external vendors
5、 Excellent communication skill with ability to function within cross functional teams.
6、 Ability to independently design experiments, analyze experimental data and present results in both non-clinical and clinical development team settings.
7、Goal oriented, organized, capable of prioritizing and working on multiple projects, and able to execute to timelines that meet company goals
?8、 Excellent verbal and written communication skills.