Review, evaluate, interpret, report, and compile non clinical toxicology, pharmacology, ADME, and drug safety data. Oversee, design, and report on nonclinical studies in accordance with international regulatory requirements. Manage contract laboratories and ensure delivery of high quality nonclinical reports that meet regulatory requirements. Author nonclinical sections o

Conduct pharmacometrics activities related to pre IND, IND, phase1 3, regulatory meetings and regulatory submissions. Provide pharmacometrics analysis and participates in activities related to analysis and reporting of pharmacometrics analyses. Author pharmacometrics sections of clinical pharmacology documents for regulatory filings including investigator's brochure, IND/

Identification and validation of patient reported outcome measures (PROMs) and Clinical Outcome Assessments (COAs; i.e., patient reported outcome [PRO], clinician reported outcome [ClinRO}, observer reported outcome [ObsRO], performance outcome [PerfO], digital health technologies [TechRO]) as well as other patient centered outcomes (e.g., patient relevant biomarkers or v