Non-Clinical Studies Manager – Northeast
Non-Clinical Studies Manager. The Non-Clinical Studies Manager will coordinate and support all aspects of non-clinical studies across global Product Development. This role includes oversight of studies at contracted Test Facilities, protocol development, bioanalytical method development/validation, drug acquisition, study execution, review of raw data, final study report review and communication with project leaders and management. The Non-Clinical Studies Manager will oversee numerous types of studies including bioequivalence, pharmacokinetic, efficacy, palatability and target animal safety.
The key responsibilities entail managing contracted test facilities in planning, conducting and reporting of non-clinical studies, monitoring study procedures, reviewing data and reports to ensure accuracy and quality. The incumbent will identify qualified animal test facilities and supporting test facilities (e.g. microbiological and bioanalytical laboratories) most suited for the study. The incumbent will coordinate audits of test facilities, will create and execute contracts and budgets with test facilities, arrange for and oversee development and validation of bioanalytical methods, manage all aspects of drug acquisition, shipping and delivery to the test facilities complying with country specific regulations. The incumbent will ensure that studies are conducted in compliance with applicable requirements, including Standards Operating Procedures (SOPs), corporate policies and regulatory requirements/guidelines (e.g., Good Laboratory Practice). The Non-Clinical Studies Manager will assist in research and design of non-clinical studies and will identify appropriate efficacy models where applicable. The incumbent will ensure that project leaders and management are fully informed of study status, issues and outcomes. The incumbent will assist with the creating, training and implementation of non-clinical SOPs and will lead the implementation of new processes or technologies related to study execution and oversight.
Qualifications include a minimum of 5 years of experience in veterinary pharmaceutical research, experience in designing and monitoring of contracted laboratory studies, experience in pharmacokinetics, bioequivalence and bioanalytical methods is preferred. Demonstrated understanding of protocols, data review, GLP regulations, basic statistics and laboratory reports. Our successful candidate will have strong analytical and organization skills with the ability to handle multiple tasks and prioritize. Ability to communicate effectively with excellent written/verbal skills and strong technical writing capabilities is essential.
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