VP, Clinical Science

🕒 il y a 3 mois

🇺🇸 États-Unis – Télétravail

⏰ Temps Plein

🔴 Expert

👔 Vice-président

🗣️🇺🇸🇬🇧 Anglais requis

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Logo of Telix Pharmaceuticals Limited

Telix Pharmaceuticals Limited

501 - 1000 employés

Fondée en 2015

🧬 Biotechnologie

💊 Pharmaceutique

⚕️ Assurance santé

Biotechnology • Pharmaceuticals • Healthcare Insurance

Telix Pharmaceuticals Limited est une entreprise biopharmaceutique en phase commerciale dédiée à transformer la manière dont les cancers et les maladies rares sont diagnostiqués et traités. En se concentrant sur le développement et la commercialisation de radiopharmaceutiques théranostiques, Telix utilise la radiation ciblée pour améliorer la prise de décisions thérapeutiques et fournir des thérapies personnalisées. Avec un vaste portefeuille dans des domaines tels que le cancer de la prostate et du rein, la neuro-oncologie et les cancers musculo-squelettiques, Telix a obtenu des approbations réglementaires mondiales pour son principal agent d'imagerie, Illuccix®, et mène activement de nombreux essais cliniques à travers le monde.

Description

• Support the design, strategy, and operationalization of clinical trials during the drug development process from Phase 0 to Phase 4 • Develop study documentation including study protocols, investigators brochures, informed consent documents, clinical dossiers for regulatory submissions • Provide scientific input into documentation including investigators brochures, investigational medicinal product dossiers, developmental safety update reports and clinical study reports • Review study data including safety and efficacy data for accuracy and quality • Triage and delegate work requests to the in-house team of subject matter experts • Work closely with Clinical Operations, Medical Affairs, and asset matrix teams to ensure compliance with organizational SOPs • Assist in development and participate as needed, in Steering Committees and Advisory Boards with global thought leaders • Provide senior management personnel regular updates on the progress of the clinical research • Review imaging studies and be qualified to provide input on interpretation, quality assurance, accuracy of imaging interpretation, and final review of imaging, protocols, and imaging charters prior to implementation • Coordinate efforts associated with clinical imaging, pharmacology, biostatistics, and physics subject matter experts to address complex trial related questions/strategy

🎯 Exigences

• Scientific background with university degree and MD required • 10+ years Clinical experience with strong sponsor or CRO experience required • 5+ years’ experience leading teams required • Detailed knowledge of global clinical trial regulations • Formal training in clinical diagnostic imaging (e.g. Radiology, Nuclear Medicine, Radiation Oncology) with Clinical Fellowship level training in Oncology associated field • Familiarity with managing groups within matrix teams

🏖️ Avantages

• Competitive salaries • Annual performance-based bonuses • Equity-based incentive program • Generous vacation • Paid wellness days • Support for learning and development

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