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Director/Vice President, Translational Research - Montréal, QC, Canada - 35Pharma
Description
Director/Vice President, Translational Research 35Pharma is a clinical-stage biopharmaceutical company that designs and develops innovative therapeutics for life threatening lung diseases, and musculoskeletal and metabolic disorders. We believe in connecting rigorous science with our innate sense of urgency to rapidly generate breakthrough therapies for patients in need to better quality of life.Our highly qualified team of drug developers and company builders has a track record of advancing complex biologics from discovery through clinical trials. Our R&D facilities are located in the heart of Montréal, Canada , and comprise laboratory space for pre-clinical research as well as manufacturing development that bolster our mission to serve patients in need.
We are currently looking for a full-time proactive, positive and self-motivated Director/Vice President, Translational Research who will join our growing team to develop medicines that radically transform patients' lives.
This position will be integral to the translation of our discovery programs into clinical development.
Under the direction of the Chief Scientific Officer and in collaboration with the Clinical and Discovery teams, the Director/Vice President, Translational Research will lead our mode of action studies across pre-clinical experiments and early clinical trials with a shared commitment to high quality and performance.
The position would be an excellent fit for a professional with demonstrated experience developing and executing biomarker discovery strategies, assessing PK/PD relationships and supporting the translation of early-stage drug discovery programs into the clinic.
You have a passion for science and drug development
Provides scientific leadership in areas of biomarker discovery, development and translational science working with multiple cross-functional teams
People management: Coach, develop and supervise a team of highly motivated translational scientists and research associates
Collaborate with Preclinical Development, Clinical Operations teams, and external experts as appropriate to develop scientifically rigorous translational and exploratory biomarker strategies that assess mode of action and PK/PD relationships across pre-clinical studies and clinical trials
Support scientific input and review of all translational medicine aspects of clinical and regulatory documents, including but not limited to development plans, study protocols, laboratory manuals, clinical study reports, regulatory submissions, and responses to any regulatory questions, etc.
Propose and develop innovative methods and technologies as well as new directions for project development
Function as a scientific and business thought-leader inside and outside of the company and a key link to external scientific and medical community
PhD (and/or MD) with primary focus in either Cellular or Molecular Biology, Medicine, Pharmacology or a related field with at least 10 years of pharmaceutical or biotechnology industry experience in pre-clinical / early clinical or translational science
Thorough understanding of clinical trials and clinical strategy, experience with drug development as well as the assessment of PD markers in a clinical setting
Proven ability to drive and influence projects from discovery through early clinical development with a focus on providing clinical proof of biology
Familiarity with data management and visualization tools and collaborating with computational biology experts to analyze complex genomic and proteomic data sets
Flexible, independent and self-motivated, able to handle multiple tasks and priorities
Directeur/ Vice-président de la recherche translationnelle
Nous croyons qu'il est important d'associer une science rigoureuse à notre sens inné de l'urgence afin de générer rapidement des thérapies révolutionnaires pour les patients qui en ont besoin et améliorer leur qualité de vie. Notre équipe hautement qualifiée de développeurs de médicaments et de bâtisseurs d'entreprises a fait ses preuves dans l'avancement de produits biologiques complexes, de la découverte aux essais cliniques.
Nos installations de recherche et développement sont situées au cœur de Montréal, au Canada, et comprennent des laboratoires pour la recherche préclinique ainsi que le développement de la fabrication qui renforcent notre mission de servir les patients dans le besoin.
Nous recherchons actuellement un Directeur/ Vice-président de la recherche translationnelle proactif, positif et motivé qui se joindra à notre équipe en pleine croissance pour développer des médicaments qui transforment radicalement la vie des patients.
Ce poste fera partie intégrante de la translation de nos programmes de la découverte vers le développement clinique. Sous la direction du chef de la direction scientifique et en collaboration avec les équipes cliniques et de découverte, le Directeur/ Vice-président de la recherche translationnelle dirigera nos études de mode d'action à travers des expériences précliniques et des essais cliniques précoces avec un engagement partagé entre des standards de qualité élevés et de performances.
Le poste conviendrait parfaitement à un professionnel ayant une expérience démontrée dans le développement et l'exécution de stratégies de découverte de biomarqueurs, l'évaluation des relations PK/PD et le soutien à la translation de programmes de découverte de médicaments à un stade précoce vers la clinique.
Vous avez une passion pour la science et le développement de médicaments
Vous vous épanouissez dans un environnement en évolution rapide avec beaucoup de responsabilités et d'opportunités d'apprentissage
Fournit un leadership scientifique dans les domaines de la découverte, du développement et de la science translationnelle des biomarqueurs en travaillant avec plusieurs équipes interfonctionnelles
Gestion des personnes : encadrer, développer et superviser une équipe de scientifiques translationnels et d'associés de recherche hautement motivés
Collaborer avec les équipes de développement préclinique, des opérations cliniques et des experts externes, le cas échéant, pour développer des stratégies translationnelles et exploratoires scientifiquement rigoureuses des biomarqueurs qui évaluent le mode d'action et les relations PK/PD dans les études précliniques et les essais cliniques
Soutenir la contribution scientifique et l'examen de tous les aspects de la médecine translationnelle des documents cliniques et réglementaires, y compris, mais sans s'y limiter, les plans de développement, les protocoles d'étude, les manuels de laboratoire, les rapports d'étude clinique, les soumissions réglementaires et les réponses à toute question réglementaire, etc.
Proposer et développer des méthodes et technologies innovantes ainsi que de nouvelles orientations pour le développement de projets
Agir en tant que leader d'opinion scientifique et commercial à l'intérieur et à l'extérieur de l'entreprise et un lien clé avec la communauté scientifique et médicale externe
Doctorat (et/ou MD) avec une spécialisation en biologie cellulaire ou moléculaire, en médecine, en pharmacologie ou dans un domaine connexe avec au moins 10 ans d'expérience dans l'industrie pharmaceutique ou biotechnologique en sciences précliniques/cliniques précoces ou translationnelles
Compréhension approfondie des essais cliniques et de la stratégie clinique, expérience du développement de médicaments ainsi que de l'évaluation des marqueurs pharmacodynamiques en milieu clinique
Capacité avérée à piloter et à influencer des projets depuis la découverte jusqu'au développement clinique précoce en mettant l'accent sur la fourniture de preuves cliniques de biologie
Expertise dans l'évaluation et le développement des relations PK/PD
Familiarité avec les outils de gestion et de visualisation des données et collaboration avec des experts en biologie computationnelle pour analyser des ensembles de données génomiques et protéomiques complexes
Flexible, indépendant et motivé, capable de gérer plusieurs tâches et priorités