Associate Director Clinical Development
il y a 4 jours
AMOLYT, SOCIETE DE BIOTECHNOLOGIE AU STADE CLINIQUE, RECHERCHE SON:
**Associate Director Clinical Development**
Idéalement basé à Lyon, CDI,
Fort de notre savoir-faire et de notre expérience dans le domaine des peptides thérapeutiques, notre vocation est de développer des traitements innovants visant à améliorer la vie des patients atteints de maladies endocriniennes rares.
A ce jour, notre portefeuille de produits en développement comprend l’AZP-3601, un traitement potentiel de l’hypoparathyroïdie (en préparation de phase 3), de l’AZP-3813, un antagoniste du récepteur de l’hormone de croissance en développement pour le traitement de l’acromégalie (en préparation de phase1) et de l’AZP-40XX, un traitement potentiel de l’hyperparathyroïdie primaire (HPTP) et de l’hypercalcémie humorale maligne (HHM) (en développement pré-clinique).
Nous appuyant sur nos résultats encourageants et sur un financement de série C de 130 millions d’euros mené par Sofinnova Partners et codirigé par Intermediate Capital Group nous poursuivons notre développement et créons le poste Associate Director.
I - LE POSTE:
Rapportant au VP, Clinical Development and Regulatory Affairs, l’Associate Director Clinical Development pilotera le développement des produits en phase 1 et 2.
Sur la base d’une très bonne connaissance scientifique du produit, il s’agira d’élaborer les meilleures stratégies de développement clinique, en s’appuyant sur des experts cliniques et médicaux partenaires et en interne
Les missions:
- Soutenir l'élaboration de plans de développement clinique : maladies cibles, populations de patients, objectifs et critères d'évaluation...
- Assurer un leadership clinique dans la conception et la conduite des essais cliniques : rédaction des synopsis, des protocoles, des formulaires de consentement...
- Diriger les examens cliniques/médicaux, l'évaluation et l'interprétation des données relatives à l'efficacité et à la sécurité afin de garantir que les données sont présentées avec l'interprétation scientifique appropriée.
- Fournir des données cliniques/médicales pour la Brochure Investigateur, les Rapports de Sécurité, les évènements indésirables, les rapports d'étude clinique, les résumés scientifiques et les publications.
- Contribuer à la formation des CRO, et des sites investigateurs.
- Contribuer au développement et au maintien des relations avec la communauté médicale, les investigateurs et les leaders d'opinion.
- Participer à l'élaboration et à la mise en œuvre de procédures conformes aux directives de la FDA et de l'ICH et aux BPC.
II - LE PROFIL DU CANDIDAT RECHERCHE:
- De Formation scientifique (PhD, MD ou Pharm D), vous justifiez d’une expérience confirmée (8/10 ans) en développement clinique dans l’industrie pharmaceutique, en Biotech, ou CROs.
Vous avez une excellente maitrise de la réglementation des essais cliniques (EU et FDA), des GCP, GMP, élaboration de design d’étude, une sensibilité aux sujets réglementaires
Une expérience en endocrinologie et métabolisme est un plus.
- Votre rigueur, vos qualités d’écoute, d’organisation, de gestion de projet, votre force de conviction et vos solides compétences en relations interpersonnelles et communication sont vos atouts pour réussir dans ce poste clé.
Prêt à accompagner le développement d’une Biotech prometteuse, rejoignez-nous
Type d'emploi : Temps plein, CDI
Statut : Cadre
Salaire : 90 000,00€ par an
Exigences linguistiques flexibles:
- Français non requis
Programmation:
- Du lundi au vendredi
- Travail en journée
Lieu du poste : En présentiel
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