Regeneron
Healthcare
AssociateDirectorPreclinical&TranslationalPK/PD
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optimal for Director candidates.
“Associate Director Preclinical & Translational PK/PD at Regeneron. Skills: PK/PD modeling, Quantitative modeling, Translational modeling. Develop quantitative and mechanistic mathematical PK/PD models. Inform preclinical-to-early clinical translation”
Industry & Context.
Scientific reasoning
What They're Looking For.
Must Have
Ph.D. or M.S. in pharmacokinetics, pharmaceutical sciences, engineering, applied mathematics or related disciplines, Track record of applying quantitative and mechanism-based PK/PD modeling and simulation approaches, Greater than 6 years of pharmaceutical industry or related experience, Experience developing and applying mechanism-based PK/PD models to guide R&D teams
Nice to Have
Familiarity with biotherapeutic modalities
What You'll Do.
Develop quantitative and mechanistic mathematical PK/PD models
Inform preclinical-to-early clinical translation
Predict human efficacious dose
Select first-in-human dose
Contribute to advancement of modeling and simulation sciences
Provide expert support to project teams
Design quantitative pharmacology studies
Execute quantitative pharmacology studies
Interpret quantitative pharmacology studies
Optimize use of mouse PK data
Inform translation to nonhuman primate and human PK
Integrate modeling and simulation analyses
Summarize modeling and simulation analyses
Present work at scientific meetings
Publish work in scientific journals
How You'll Work.
Team & Collaboration
Multidisciplinary project teams; Clinical Pharmacology; Quantitative Pharmacology; R&D
Communication Scope
Scientific presentations
Full Job Description
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. **A Typical Day May Include:** * 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 **This role might be for you if:** * 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 develo
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