Toxicologist 1

At ITR Laboratories Canada INC

Our Mission is to bring new medicines to the world which relieve patients suffering from serious diseases.

ITR Laboratories Canada has been servicing the pharmaceutical and biotechnology industries for over 30 years and has established itself as a trusted partner worldwide in Drug Safety Testing. We are actively seeking a **Study Director-Toxicologist** to join our team as we continue to expand our reach and services.

**Main Responsibilities**:

- Represent the single point of study control.
- Has overall responsibility for the technical conduct of the study through to the final report and archiving.
- Responsible for the interpretation, analysis, documentation and reporting of results
- Ensure that the study plan, including any change, is approved by the SD
- Ensure that the study plan is signed by the sponsor.
- Ensure that all experimental raw 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 the procedures specified in the study plan are followed.
- Assess and documents the impact of any deviations from the plan on the quality and integrity of the study and takes appropriate corrective action if necessary.
- Acknowledge deviations from Standard Operating Procedures during the conduct of the study.
- Review the study raw data at intervals.
- Ensure that all applicable Good Laboratory Practice (GLP) regulations are followed.
- Ensure that all raw data, documentation, study plan and any amendments, specimens, and final reports and any supporting material are transferred to the archives.
- Ensure that the Quality Assurance personnel have a copy of the study plan and any amendments in a timely manner and communicate effectively with quality Assurance personnel as required during the conduct of the study.
- Ensure that study plan and amendments and Standard Operation Procedure are available to study personnel.
- Ensure that the study plan and final report for a multi-site study identify and define the role of any Principal Investigator(s) and any test facilities and test sites involved in the conduct of the study.
- Ensure that computerized systems used in the study have been validated.
- Ensure that analytical methods used in the study have been validated appropriately for study sample analysis.
- Sign and date the final report to indicate acceptance of the responsibility for the validity of the data and to indicate the extent to which the study complied with these Principles of Good Laboratory Practice.

**Requirements**:

- Minimum of a Bachelor’s Degree in a related field,
- Ideally, 3-5 years of experience as Study Director.
- Experience working with laboratory rodents and large animal species
- Proficient in English (spoken and written) and able to communicate in French
- Superior report writing abilities
- Experience in a CRO is an Asset
- Autonomous, organized with the ability to lead and motivate a team
- Be conversant, and function in compliance with the guidelines and regulations published by governmental regulatory bodies (OECD, FDA, EU and ICH).

**This position offers**:

- Permanent full-time job, 37.5 hours / week;
- Group insurance plan and group RRSP.
- A stimulating and friendly work environment.

Start Date: ASAP