VP, Clinical Science

🕒 Fevereiro 19

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Telix Pharmaceuticals Limited

SiteLinkedInTodas as Vagas

501 - 1000 funcionários

Fundada em 2015

🧬 Biotecnologia

💊 Farmacêutico

⚕️ Seguro de Saúde

Biotechnology • Pharmaceuticals • Healthcare Insurance

A Telix Pharmaceuticals Limited é uma empresa biofarmacêutica em estágio comercial dedicada a transformar a forma como o câncer e doenças raras são diagnosticados e tratados. Com foco no desenvolvimento e comercialização de radiofármacos teranósticos, a Telix utiliza radiação direcionada para aprimorar a tomada de decisões terapêuticas e oferecer uma terapia personalizada. Com um extenso pipeline que aborda áreas como câncer de próstata e rim, neuro-oncologia e cânceres musculoesqueléticos, a Telix obteve aprovações regulatórias globais para seu principal agente de imagem, o Illuccix®, e está conduzindo ativamente inúmeros ensaios clínicos em todo o mundo.

Descrição

• 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

🎯 Requisitos

• 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

🏖️ Benefícios

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