You will be responsible for data analysis and result interpretation of clinical studies. You may also work with experienced team member to contribute to a study design, data analysis plan development, TLF (Table, Listing, Figure) design, and result report as well.
- Work independently or collaboratively with experienced team member in clinical pharmacology supporting ongoing projects.
- Perform or assist with PK/PD analyses including modeling and simulation for understanding of the PK/PD relationship of drug candidates.
- Review and QC analysis results and outputs for other team members.
- Ensure working process following good practice of study requirement and SOPs.
- Participate in ongoing group meetings and project team meetings including data analysis, slide preparation for study updates and identified issues.
- Be exposed to various other functions within the clinical pharmacology.
- Master degree in pharmacokinetics, pharmaceutical sciences, or related discipline; Ph.D. or Pharm.D. will be a plus
- Hands-on experience in PK / PD analysis, or clinical pharmacology or related experience
- Understanding of China, US, European, or other countries / regions regulatory requirements and guidelines
- Solid knowledge of pharmacokinetic principle and drug development process
- Must be proficient with at least one PK analysis software such as Phoenix WinNonlin, NONMEM etc.
- Ability to interpret analysis results and impact on the study medication
- Familiar with ICH/GCP guidelines, and FDA, EMA, and CFDA guidance
- Proficient in spoken and written English
备注： ‘职位年薪’ 仅供参考，具体薪资和福利将根据候选人经验和能力综合评定。