- Recruitment Type：Social Recruitment
- Work Type：Full-Time
Participate in designing the early development plan and overall translational medicine and clinical pharmacology plan for the different steps of clinical development, according to the strategy developed by the Company,
Support NCA PK analysis for clinical studies,
Involve in pharmacometrics analysis of clinical PK data,
Organize and supervise tests of new products to ensure quality,
Review and prepare documents for regulatory submission including clinical development plans, Investigator’s Brochure and the Clinical Pharmacology section of INDs, CTAs and/or NDAs,
Manage collaborations with CRO for outsourcing activities and ensure high quality study execution to meet program timelines.
MS/PhD in Pharmacokinetics, Pharmaceutical Sciences, Pharmacology, or related discipline.
2+ years of biotech/pharmaceutical drug development experience as a subject matter expert in pharmacokinetics or a related discipline.
Basic scientific computing and programming skills in a variety of computational tools such as WinNonlin/Phoenix, NONMEM, R, Berkeley Madonna is preferred.
In-depth knowledge of pharmacokinetic and pharmacodynamic principles.
Good written and oral presentation capabilities.
- Work Experience：Working experience not required
- Language：Not Required