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

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

The Otsuka US Legal Affairs department is looking to hire an experienced attorney familiar with pharmaceutical pricing, reimbursement, market access contracting strategies and commercializing approved products. This role requires a candidate who has understanding of and several years of experience with the legal and business risks specific to pharmaceutical product pricin

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/