Toxicologist Study Director

Bayer Direct Services GmbH; Valbonne; Sur place; EUR 70 000 - 90 000; Plein temps

Résumé du poste

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 d'équipe et une maîtrise de l'anglais. Ce rôle est essentiel pour soutenir les produits de la division Crop Science de l'entreprise.

Qualifications

• Niveau élevé d'éducation en Toxicologie ou une science étroitement liée.
• Au moins 7 ans d'expérience réussie dans le domaine.
• Connaissance et utilisation de l'anglais (écrit et oral).

Responsabilités

• Agir en tant que Directeur d'étude pour des études toxicologiques.
• Définir les objectifs et superviser l'ensemble des études.
• Coordonner avec d'autres scientifiques et établir les conclusions finales.

Connaissances

Compétences managériales

Résolution de problèmes

Communication

Formation

PhD en Toxicologie ou domaine connexe

Description du poste

Retour aux résultats

Société

Bayer Direct Services GmbH

Lieu(x)

Sophia Antipolis Postulez maintenant

Sauvegarder CDI Industrie Pharmaceutique

Cadre

Direction

Santé

Publiée depuis 1 jour

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, animale et végétale. La division Crop Science propose des semences de haute qualité, des solutions innovantes de protection des cultures à base de produits de synthèse ou biologiques, et des outils et services pour l’accompagnement d’une agriculture moderne et durable. Dans le domaine non agricole, CropScience développe des produits et services destinés à la lutte antiparasitaires. Chez Bayer, vous avez l’opportunité d’intégrer une entreprise dont la culture valorise la passion des salariés à innover et leur donne le pouvoir de changer.

Mission

Study Director in Toxicology

• Act as Study Director for for in-vitro and in-vivo 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 à 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 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.
• 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 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.
• 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.

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 project using animal (Directive 2010/63/ EU) : Level 1 / B.
• Knowledge and use of English (written and oral).
• Managerial skills : 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.