The PK Scientist – Modeling & Simulation will be a key team member of the Translational Sciences team and will work closely with the Regulatory and Clinical Operations teams. This individual will independently and creatively use modeling and simulation tools to enhance quantitative decision making. The modeling and simulation activities include non-clinical and clinical modeling and simulation, including but not limited to, population PK/PD models, translational models, clinical trial simulations, literature meta-analysis, and other innovative, state-of-the-art modeling and simulation techniques.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
- Excellent understanding of theory, principles and statistical aspects of advanced mathematical modeling and simulation
- In depth, hands-on knowledge and experience with modeling and simulation software and applications in the area of PKPD modeling, simulation and statistics (Phoenix WinNonlin, Phoenix NLME, NONMEM or comparable applications)
- Lead all modeling and simulation efforts at Impel and bring a solid understanding of the principles of pharmacokinetics (non-compartmental, compartmental, PBPK) and biopharmaceutics to the team
- Build on solid foundation of quantitative skills to develop mechanistically-relevant PK-PD models
- Drive to the understanding of the covariates that contribute to variability in PK and/or PD
- Translate/condense/summarize outcomes of modeling and simulation analyses into information that can be used by project teams, presented internally or externally
- Support comparative BA and BE clinical study design through PK modeling and statistical assessments
- Conduct clinical trial simulations
- Conduct simulations to characterize PK/PD in special populations (pediatrics) and translational models
- Contribute to pre-INDs, INDs, NDAs and work closely with the Regulatory team on submissions
EDUCATION, EXPERIENCE AND/OR SKILLS REQUIRED
- Ph.D. in pharmacokinetics, pharmaceutical sciences, pharmacology, biostatistics or similar disciplines where modeling and simulation is emphasized
- 5+ years of industrial experience in practical applications of modeling and simulation is required
- Independent, self-starter, positive attitude
- Creative problem-solver and ability to efficiently and effectively implement models at Impel
- Highly organize and outstanding written and oral communication skills
- Ability to keep up-to-date with and propose the implementation of scientific and technological developments in the area of PK-PD modeling and simulation
- Advanced understanding of the global drug development process and collaborations among multiple functions from discovery to commercialization
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Must have demonstrated ability to multitask in high pressure, changing conditions. Ability to use computer, telephone, and other office machines.
This is a fast-paced environment with moderate noise level.
Up to 10% travel may be required.