Experience in leading the design and execution of clinical pharmacology studies including bioequivalence, drug-drug interaction, special population, ethnic sensitivity, ADME and pediatric studies and integrating results into regulatory filings, and product labels.
The individual will be responsible for the designing, planning and execution of clinical pharmacology strategies & studies in support of development of small and large molecule drugs & cutting-edge novel modalities.
The successful applicant will partner with laboratory operations staff, software engineers, and quality/regulatory specialists to increase laboratory efficiency, optimize existing assays, ensure data quality across multiple partner laboratories and develop new technologies/protocols for improving all aspects of genomic data production.
The Clinical Lab Scientist Coordinator performs chemical, microscopic, and/or bacteriologic tests and verifies results for use in the diagnosis and/or treatment of disease. This position also coordinates the technical operations of the laboratory sections for which responsible while also demonstrating competency in patient testing for neonate, pediatric, adult, and geriatric patients.
In this role, you will be responsible for the training environment, performs tests on post-verified patient specimens and unknowns and reviews results with supervisor or designee for competency assessment.