Responsibilities:
- Independently develop and implement quantitative and mechanistic mathematical PK/PD models to inform preclinical-to-early clinical translation, including human efficacious dose predictions and first-in-human dose selection.
- Contribute to the advancement and strategic direction of modeling and simulation sciences.
- Provide expert support to pre-clinical PK/PD project representatives and R&D teams to design, execute, and interpret in vitro and in vivo quantitative pharmacology studies, including optimizing use of mouse PK data to inform translation to nonhuman primate and human PK.
- Integrate and summarize modeling and simulation analyses into usable information for multidisciplinary project teams.
- Stay current on emerging science and literature and collaborate with experts in Clinical Pharmacology, Quantitative Pharmacology, and R&D.
- Present at internal/external scientific meetings and publish in scientific journals.
Qualifications / Required:
- Ph.D. or M.S. in pharmacokinetics, pharmaceutical sciences, engineering, applied mathematics, or related disciplines.
- Track record applying quantitative and mechanism-based PK/PD modeling and simulation to advance therapeutics discovery/development.
- 6+ years pharmaceutical industry or related experience developing and applying mechanism-based PK/PD models to guide R&D teams from early discovery to IND-stage clinical development.
Skills / Preferred:
- Experience with modeling and simulation platforms (e.g., Phoenix NLME, NONMEN, Monolix, ADAPT, MATLAB, SimBiology).
- Strong pharmacokinetics foundation (non-compartmental, compartmental, PK/PD, PBPK).
- Familiarity with biotherapeutic modalities (monoclonal/bispecific antibodies, gene therapy, CAR-T, siRNAs, other targeting agents).