Study Director

Role Summary

The Research Scientist/Study Director will engage in serving as the single point of study control and is responsible for the overall planning and conduct of the non-clinical investigations in accordance with applicable regulatory guidelines and contemporary scientific practice. Additionally, the RS will ensure that all Good Laboratory Practices (GLP) are met and the outcome of the study is valid and reliable.

**We are specifically looking for an experienced Toxicologist in the CRO Industry, with 5-7 years of experience.

Role Responsibilities

• Represent the single point of control for all aspects of a study while serving as Study Director for non-clinical studies.
• Responsible for the technical conduct of the study as well as for the interpretation, analysis, documentation, and reporting of results.
• Generate protocol and ensure that the protocol, including any changes, are approved and followed.
• Ensure all experimental data, including observations of unanticipated responses of the test system, are accurately recorded and verified.
• Ensure that unforeseen circumstances that may affect the quality and integrity of the nonclinical laboratory study are noted when they occur, and corrective action is taken and documented.
• Ensure that Test systems are as specified in the protocol.
• Ensure compliance with the protocol, amendments, and regulatory agencies as identified in the protocol and SOPs.
• Ensure that all raw data, documentation, protocols, specimens, and final reports are archived at the conclusion of a study.
• Interface with Sponsors, Vendors, Contributing Scientists and Principal Investigators.
• Other duties as assigned

Role Requirements

• Master’s Degree or equivalent in a related discipline required, PhD preferred.
• 5 years of experience in a GLP-compliant laboratory preferred.
• Experience with peer-reviewed publications, presentations, and scientific writing.
• Proficiency with Microsoft Office and the ability to learn and use additional applications.
• Excellent written and oral communication skills.
• Knowledge of GLPs (FDA, OECD, and MHLW) and other federal regulations relating to the care of laboratory animals.
• Ability to handle common laboratory species.
• Strong understanding of study design and protocols.
• Strong understanding of laboratory operations and data collection.
• Ability to work under specific time constraints.