Professional Profile
Dr. Karen Dingley is a Senior Consultant in ToxStrategies’ Pharmaceuticals Practice. She has more than 20 years experience in the pharmaceutical arena and previously directed efforts on the use of drug metabolism and pharmacokinetics (DMPK) at several leading pharmaceutical companies. This work included representing DMPK on cross-functional teams, as well as preparing project strategies and development plans, overseeing study design and data interpretation, working with contract research organizations (CROs), and collaborating to design and interpret PK/PD and efficacy studies. Dr. Dingley’s experience ranges from providing preclinical absorption, distribution, metabolism, and excretion (ADME) support to contributing to regulatory documents and filing investigational new drug applications (INDs). She is proficient in managing interdisciplinary projects involving chemists, biologists and clinicians.
Dr. Dingley has significant experience in authoring and critically reviewing source reports, INDs, clinical protocols, investigator brochures and briefing books to support clinical trials. She is well versed in the regulations that govern the use of human and animal subjects in research. Dr. Dingley is also experienced in performing human PK and dose predictions to support first-in-human (FIH) clinical trials, and in assessing drug-drug interaction potential.