The pharmacokinetic scientist III will serve as a primary source of scientific support for the design, analysis, reporting, and presentation of in vitro in vivo correlation initiatives. In close collaboration with the R&D team, the individual will work to continuously improve the effectiveness and contribution to the overall success rate of the BE studies. In addition, the pharmacokinetic scientist will perform pharmacokinetic analysis, interpretation and reporting of bioequivalence study results The individual will also contribute statistical expertise to the study design of bioequivalence and clinical trials.
Responsibilities and Duties:
Perform in vitro in vivo relationship (IVIVR) and correlation (IVIVC) to enable formulation design plan for various dosage forms to achieve BE using a variety of scientific tools and methodologies e.g simulations, modeling in order to support product development
Identification of biorelevant in vitro tests through IVIVR
Writing of project reports IVIVC/R report
Provide training to clinical staff on IVIVC/R
Review study design for single dose, multiple dose, pharmacodynamics and clinical studies for bioequivalence
Evaluate and implement new innovative techniques and software
Provide statistical support. e.g. Perform sample size calculations
Education and Experience
Ph.D. degree in pharmacology, pharmacokinetic, or related filed with 3 years of experience or M.Sc degree with minimum 8 years’ experience in the pharmaceutical industry.
Skills, Knowledge and Abilities
- Demonstrated experience using in silicon analysis tools such as WinNonlin, SAS, NonMEM, Trial Simulator, GastroPlus; Hands-on experience with WinNonLin/Phoenix is required;
- Expertise in IVIVC/R for modified release products,
- Good knowledge of biostatistics,
- Effective in oral, written communication and presentation skills,
- Works independently with minimal supervision.