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Recruiting: Senior Study Director, Toxicology
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A. General Purpose and Scope: Serves as a Study Director on cardiovascular, central nervous system &/or respiratory safety pharmacology studies in rodents and non-rodents, as described in ICH and GLP regulations/guidelines. Has overall responsibility for the technical conduct of a study as well as for the interpretation, analysis, documentation and reporting of results. B. Duties and Responsibilities: - Coordinates efforts of the study team - Develops protocols and ensures that the protocol, including any changes, is approved and is in compliance with the appropriate SOPs, GLPs, and regulatory agency guidelines - Reviews cost estimates to ensure that all protocol/amendment driven workscope specifications have been included in the price estimation. - Monitors financial status of ongoing studies. - Monitors progress and status of assigned studies. Ensures that all experimental data, including observations of unanticipated responses to the test system, are accurately recorded and verified. - Directs analysis of data, preparation of reports, ensures compliance with protocol and regulatory requirements, and submits them to the client - Peer reviews protocols and reports for other Study Directors - Participates in client visits - Performs other related duties as assigned II. Education/Qualifications: Required: - Ph.D., DVM, or equivalent degree - Experience may be substituted for education. III. Experience Required: - 3-5 years experience |
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