The Associate Director of Translational/Preclinical Modeling develops and implements quantitative and mechanistic PK/PD models to aid in the understanding of target biology, therapeutic modality selection/optimization, and contributes to early clinical trial dose selection and/or design and advancement and strategic direction of modeling and simulation sciences.
- Independently develops and implements quantitative and mechanistic mathematical PK/PD models that inform preclinical-to-early clinical translation, including human efficacious dose predictions and first-in-human dose selection.
- Actively contributes to the advancement and strategic direction of modeling and simulation sciences
- Provides expert support to pre-clinical PK/PD project representatives and R&D project teams to design, execute and interpret in vitro and in vivo quantitative pharmacology studies. This included working with the Research PK group to optimize use of mouse PK data to inform translation to nonhuman primate and human PK.
- Effectively integrates and summarizes modeling and simulation analyses into useable information for multidisciplinary project teams.
- Remains apprised of emerging science and literature, and effectively collaborates with subject matter experts in Clinical Pharmacology, Quantitative Pharmacology and R&D to advance modeling and simulation sciences.
- Presents work at internal/external scientific meetings and publishes work in scientific journals
- Experience using one or more modeling and simulation platforms (e.g., Phoenix NLME, NONMEN, Monolix, ADAPT, MATLAB, SimBiology, etc.)
- Strong theoretical and practical foundation in pharmacokinetics, including non-compartmental, compartmental, PK/PD and PBPK.
- Effectively work in a fast-paced, highly-matrixed team-based environment and leverages scientific reasoning to influence key stakeholders.
- Ability to learn new areas of biological sciences to develop quantitative and mechanistic PK/PD models for emerging therapeutic modalities.
- Familiarity with biotherapeutic modalities, including monoclonal and bispecific antibodies, gene therapy, CAR-T, siRNAs and other targeting agents preferred
Ph.D. or M.S. in pharmacokinetics, pharmaceutical sciences, engineering, applied mathematics or related disciplines with a track record of applying quantitative and mechanism-based PK/PD modeling and simulation approaches to advance the discovery and development of therapeutics. Greater than 6 years of pharmaceutical industry or related experience in developing and applying mechanism-based PK/PD models to guide R&D teams from early discovery to IND-stage clinical development.