Primary Function:
This job is a quantitative pharmacology position in Zailab within Clinical Pharmacology department. This position will be responsible for modeling and simulation during various stages of clinical development including but not limited to translational PK/PD analyses, population PK (PK/PD) analyses, exposure-response analyses, etc.
Major Responsibilities and Duties:
- Conduct PK/PD modeling and simulation analyses, including translational PK/PD analyses, population PK analyses, population PK/PD analyses, Exposure-Response analyses and other model-based analyses as appropriate.
- Work collaboratively within a multi-discipline team, to support critical decision making such as study design, dose selection, probability of success estimation with M&S expertise in multiple projects.
- Contribute to the development and execution of M&S plans, as well as present plans and results within a multi-discipline team.
- Develop and review study designs, analysis plans, analysis reports, and interpret PK/PD data and results.
- Contribute to continuous improvement of M&S capacities within department, through supporting training activities, evaluating and applying novel M&S tools/approaches as appropriate.
- Support clinical pharmacology function from pre-IND to post approval for both small and large molecules.
- Serve as SME on due diligence projects.