Senior Toxicologist/Study Director

RTI's Life Sciences and Toxicology unit is seeking an experienced Senior Toxicologist/Study Director.  The candidate is expected to be multi-skilled and have a broad-based education in the biological sciences, which ideally incorporates multiple disciplines including pharmacology, endocrinology, pharmacokinetics, toxicokinetics, statistics, clinical pathology, toxicology and histopathology.   They must have a detailed knowledge of Good Laboratory Practice, of local and worldwide Regulatory Guidelines,  professional integrity, effective written and oral communication, good data interpretation skills and the organizational and networking skills to ensure that the study progresses according to the agreed plan and to the highest scientific and technical standards.

 

Candidate will serve as a Toxicology Study Director, as described in the GLP regulations with responsibilities including but not limited to:

 Overall responsibility for the technical conduct of a study as well as for the interpretation, analysis, documentation, and reporting of results.  Oversight of the nonclinical safety evaluation programs for selected drug candidates, as well as for the review of protocols, reports, and regulatory documents and attendance at internal decision making meetings as appropriate.   Assist in the proper design, efficient execution, and timely reporting of single dose toxicity, repeat dose toxicity, carcinogenicity, DART and other toxicity studies in animals.  Ensure the compliance of Drug Safety Evaluation studies with worldwide regulatory requirements and Good Laboratory Practice Regulations.  Maintain knowledge of worldwide testing and registration requirements.  On an as needed basis, interact with regulatory agencies.    Provide scientific collaboration to exploratory and discovery groups within RTI.  Continuously evaluate and apply new scientific methodology in order to maintain scientific excellence.

 

 

Additional Responsibilities:Coordinates efforts of the study team.Develops protocols and ensures that the protocol, including any changes, is approved and is in compliance with appropriate SOPs, GLPs, and regulatory agency guidelines.Reviews cost estimates to ensure that all protocol/amendment driven work or scope 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 preparation of reports, ensures compliance with protocol and regulatory requirements, and submits them to the client.Peer reviews reports of other Study Directors.Participates in client visits.Performs other related duties as assigned.

 

 

Minimum Qualifications:Ph.D., DVM or equivalent with knowledge of toxicology in drug development.3-5 years or more experience in overseeing the conduct of toxicology studies for the registration of pharmaceuticals and interpreting the significance of the results from those studies.  Mastery of principles of effective written and oral communication, especially as they pertain to writing clear, accurate and complex toxicology reports for IND and NDA submissions. Knowledge of human risk assessment, as it pertains to applicable discipline. Ability to design and interpret toxicology studies exploring mechanisms of toxicology involving biochemical, functional, and or structural endpoints. Knowledge of Good Laboratory Practice, regulatory requirements, and drug development processes.  DABT certification desirable.

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