Toxicologist Study Director

il y a 2 jours


Valbonne, France Bayer Temps plein

Study Director in Toxicology (F/H/NB) Be the single point of study control with ultimate responsibility for the overall conduct of the study and the compliance of the study and its final report with the French and OECD Principles of Good Laboratory Practice and international regulatory guidelines (when applicable). Be responsible for study plan design and approval, as well as overseeing data collection, analysis and reporting. Ensure that the scientific, administrative and regulatory aspects of the study are controlled and assume responsibility for the fidelity and validity of the data and the degree of compliance with GLP. As principal investigator, ensure that the delegated phases of the study are conducted according to the Quality Management System and applicable Principles of Good Laboratory Practice if applicable. Your Roles And Responsibilities Act as Study Director for in‑vitro and in‑vivo toxicological studies ensuring the use of appropriate standard operating procedures according to the Quality Management System, the respect of all international regulatory guidelines and in accordance with GLP principles as described in the French Environment Code. Define the objectives and whole conduct of the study and how they are to be achieved in a study plan and subsequent amendments that should be made available to all personnel involved 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 draw 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. Ensure that all raw data generated are fully documented and recorded. Ensure that computerized systems used in the study have been 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 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. Added value: The results of these studies are the basis for input into decisions regarding promotion or stopping of compounds, resolution of critical issues on compounds, and supporting the products of Bayer Crop Science Division in both the regulatory and public arena. Toxicologist Contribute to the development of new experimental protocols or new methods related to chemical families or client requirements. 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. Manage research projects including follow‑up of studies, budgets, communication of results, reports and costs, within negotiated deadlines and coordinate research activities with external laboratories. Actively contribute to international working groups to advance best practices in toxicology, fostering collaboration and driving innovation in global safety standards. Challenge the status quo by proactively advocating for the adoption of innovative tools in toxicology, including data digitalization and automated reporting, to enhance efficiency and modernize toxicology practices. Your profile : 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 projects using animals (Directive 2010/63/EU): Level 1/B. Knowledge and use of English (written and oral). Managerial skills: Ability to manage and motivate teamwork on routine/research projects. Strength in communication and problem solving. Knowledge of international regulatory guidelines and GLP principles. Additionnal information : Contract : permanent Location : Sophia Antipolis (06) - FR Qui sommes‑nous ?Bayer est un groupe international dont les cœurs de métier se situent dans les secteurs de la santé et de l’agriculture. A la confluence de la chimie et de la biologie, Bayer contribue à améliorer la qualité de vie en proposant des produits et services en santé humaine et végétale.Chez Bayer nous sommes chaque jour motivés par les grands défis de notre époque… Pour Bayer, l’égalité des chances est un axe majeur de la responsabilité sociétale de l’entreprise. Lieu: France : Alpes Maritimes : Sophia Division: Crop Science Code de référence: 857848 Seniority level Mid‑Senior level Employment type Full‑time Job function Research, Analyst, and Information Technology Industries Chemical Manufacturing, Pharmaceutical Manufacturing, and Biotechnology Research Referrals increase your chances of interviewing at Bayer by 2x. #J-18808-Ljbffr


  • Toxicologist Study Director

    il y a 1 semaine


    Valbonne, France Bayer CropScience Limited Temps plein

    Toxicologist Study Director (F/H/NB) Study Director in Toxicology (F/H/NB) Study Director in Toxicology: Be the single point of study control with ultimate responsibility for the overall conduct of the study and the compliance of the study and its final report with the French and OECD Principles of Good Laboratory Practice and international regulatory...


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  • Valbonne, France Bayer Direct Services GmbH Temps plein

    Une entreprise internationale de santé recherche un Directeur d'Étude en Toxicologie à Sophia Antipolis. Vous serez responsable de la gestion d'études toxicologiques in vitro et in vivo, assurant le respect des normes réglementaires. Le candidat idéal aura un doctorat en toxicologie ou une expérience pertinente, de solides compétences en gestion...