R&d Clinical Manager
Il y a 5 mois
Rattaché à un site de Recherche et Développement d'un grand groupe pharmaceutique de dimension mondiale, regroupant une centaine de collaborateurs opérant dans des installations de recherche animale de niveaux de biosécurité 1 à 3+, accrédité AAALAC, vous assurez le rôle de Responsable d'Etude en charge de la conduite des études pré-cliniques.
Missions Principales:
- Aide à l'initiation et à la coordination d'expériences scientifiques avec un objectif prédéfini, y compris le développement de nouvelles méthodologies, protocoles et/ou procédures d'essai qui contribuent à l'innovation et aux objectifs des groupes projets de recherche et développement, et reflétant son expertise. Prend en charge la conception globale de l'étude, son exécution et aide à la planification des ressources et du budget, de la préparation du protocole au reporting, pour répondre aux objectifs projet ou de soumission aux autorités règlementaires pour les études animales en condition laboratoire et terrain.
- Membre clé des équipes qui conçoivent des études cliniques pour l’obtention, dans les autorisations de mise sur le marché des nouveaux produits, des revendications définies en équipe projet, en conformité avec les règlementations internationales et les normes de l'entreprise pour l'intégrité des données et le bien-être des animaux Assume les rôles de moniteur et d’investigateur si nécessaire. Membre clé des équipes responsables de la conception, de l'organisation, de la réalisation, et de la production de rapports des études cliniques de R&D, selon les timings pré-définis, afin de démontrer l'innocuité et l'efficacité des nouveaux produits, de développer de nouvelles revendications thérapeutiques et utilisations pour les produits existants. Assure la conformité dans le domaine des BPL, BPC, Pharmacovigilance, bien-être animal et exigences réglementaires locales.
Contribuer ou diriger des initiatives internes telles que l'élaboration de procédures, le dépôt de brevets et due diligence.
Soutenir le vétérinaire désigné dans la conduite des soins : en fonction des besoins, superviser ou réaliser des examens cliniques (à l'arrivée, en quarantaine, acclimatation, en stock ou étude), des traitements (définition et mise en œuvre), le suivi des soins et d'éventuelles autopsies et prélèvements avec l'aide des équipes compétentes de technicien animaliers, selon leurs responsabilités.
Participe au service vétérinaire du site.
Contribuer à l'évaluation et à l'amélioration de la qualité des interventions chirurgicales et médicales, en particulier l'asepsie, l'anesthésie, l'analgésie et les soins pré- et postopératoires.
Contribuer à la SBEA.
Assurer le suivi scientifique et technologique dans ses domaines de responsabilité
Profil Recherché:
- Expérience en recherche et développement préclinique et clinique de produits vétérinaires souhaitée.
- Vous connaissez l’expérimentation animale, leurs principes et leurs règlementations. L'expertise dans le domaine aviaire serait un atout supplémentaire.
- Vous êtes un Vétérinaire et avez une spécialisation en médecine interne, ou une autre spécialité.
- Vous parlez couramment l'anglais oral et écrit et avez de bonnes compétences en rédaction scientifique en français et en anglais
- Vous êtes autonome, rigoureux et analytique. Vous êtes axé sur la qualité et avez l'esprit d'équipe et le leadership nécessaires pour mener à bien les missions qui vous sont confiées.
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