VacantSophiaStudy Director Toxicologist H/F - Bayer

Study Director in Toxicology :
- Act as Study Director for toxicological studies ensuring the use of appropriate standard operating procedure according to the Quality Management System, the respect of all appropriate international regulatory guidelines and in accordance with GLP principles as described in the French Environment Code (Article Annexe II a l'article D523-8) on a range of different study types.
- Define the objectives and the whole conduct of the study and how they are to BE achieved in a study plan and subsequent amendments that should make available to all personal involved including quality assurance staff before the starting date.
- Ensure that the study plan and the 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 and coordinate all phases.
- Coordinate with other study scientists, and/or Principal Investigator(s) all phases of the study and drawing the final overall conclusions from the study.
- Ensure that the procedures, guidelines or regulatory documents specified in the study plan are followed and assess and document the impact of any deviations from the study plan on the quality and integrity of the study, and take appropriate corrective action if necessary; acknowledge deviations from Standard Operating Procedures during the conduct of the study.
- Ensure that all raw data generated are fully documented and recorded.
- Ensure that computerized systems used in the study have been Key Tasks : validated.
- Sign and date the final report to indicate acceptance of responsibility for the validity of the data and to indicate the extent to which the study complies with these Principles of Good Laboratory Practice - Ensure that after completion (including termination) of the study, the study plan, the final report, raw data and supporting material are archived.
- Request and coordinate resources provided by management, such as personnel, equipment and facilities, to ensure they are adequate and available as scheduled for the proper conduct of the study. Toxicologist :
- Contribute to the development of new experimental protocols or new methods related to chemical families or client requirements.
- Support the developmental toxicity activities by providing expertise, maintaining a high level skill and contributing to research projects.
- Ensure and promote an ethical, humane and responsible use of animals in accordance with the European directive 2010/63/UE and the French Decree No. 2013-118 of February 1, 2013 relating to the protection of animals used for scientific purposes - As part of the scientific programs developed, manage research projects including the follow up of studies, budgets, communication of results, reports and costs, within the negotiated deadlines and coordinate research activities with external laboratories High level of education in Toxicology or a closely related science (PhD / Doctorate) or at least 7 years of successful experience in the field. Ability to conduct scientific project using animal (Directive 2010/63/EU) : Level 1/B. Knowledge and use of English (written and oral). Ability to manage and motivate team work on routine/research projects. Strength in communication and problem solving. Knowledge of international regulatory guidelines and GLP principles