Associate Director Preclinical & Translational PK/PD
Core
Develops and implements quantitative and mechanistic PK/PD models to inform preclinical-to-early clinical translation, including human efficacious dose predictions and first-in-human dose selection.
Role type
Associate Director, Translational/Preclinical Modeling
Builds
Quantitative and mechanistic mathematical PK/PD models for therapeutic modality selection and early clinical trial design
Domain
Biopharmaceuticals, Pharmacokinetics/Pharmacodynamics (PK/PD)
Deliverable
production ML models
Required skills
Mechanistic PK/PD modeling, Non-compartmental analysis, Compartmental modeling, PBPK modeling, Mathematical modeling, Statistical analysis, Scientific reasoning, Stakeholder influence
Preferred skills
Biotherapeutic modalities (mAbs, bispecific antibodies, gene therapy, CAR-T, siRNAs), Modeling platforms (Phoenix NLME, NONMEM, Monolix, ADAPT, MATLAB, SimBiology)
Technologies
Phoenix NLME, NONMEM, Monolix, ADAPT, MATLAB, SimBiology
Responsibilities
Develop and implement quantitative and mechanistic mathematical PK/PD models; Contribute to the strategic direction of modeling and simulation sciences; Provide expert support to design, execute, and interpret in vitro and in vivo quantitative pharmacology studies; Integrate modeling and simulation analyses for multidisciplinary project teams; Collaborate with subject matter experts in Clinical Pharmacology and Quantitative Pharmacology; Present work at internal/external scientific meetings and publish in scientific journals
Seniority
Senior, hands-on IC with strategic direction responsibilities