Global Clinical Program Lead- Late Development Oncology

hace 2 meses


Barcelona, España Astrazeneca A tiempo completo

.Do you have expertise in, and passion for clinical drug development? Are you looking to transform the way cancer is treated and truly improve patient outcomes? Driven by our curiosity, passion and determination we are paving the way to change the practice of medicine in OncologyAstraZeneca's Oncology Research and Development teams push the boundaries of science, changing the lives of patients living with cancer. Our Clinical Development teams are united around our vision to eliminate cancer as a cause of death. Late Clinical Development is accountable for late phase drug development activities related to late-stage trials leading to drug approval by regulatory agencies, including phase 2 and 3 clinical trials.As a Global Clinical Program Lead, you will work cross-functionally to support the design, conduct, monitoring and data interpretation across a cluster of indication-aligned studies. GCPLs are strategic and patient-focused, generating opportunity with an ambitious approach to maintain a competitive advantage. This role is applied to portions of the program that have the highest degree of complexity based upon the known science or the size of the program and may also include a third-party collaboration. You will ensure that the data collected within the studies allows the determination of the benefits and risks of the compound and meet the needs of the intended label indication and price in markets globally.Responsibilities include:Own the design, delivery, and interpretation of clinical studies, ensuring the ethical and scientific integrity of the plans, studies and products in compliance with AZ policies, Good Clinical Practice and regulatory guidelines.Ensure overall clinical and scientific content for the product or indication(s) aligned to Global Product Team strategy.Represent the company to investigators and sites, regulators, ethic committees, marketing companies by delivering clinical information, providing clarification and resolving medical issues with the study team.Provide strategic knowledge and support to the Medical Directors and Development Scientists for initiation, execution and completion of the clinical studies.With the GCH, provide strategic feedback on development decision points and target labeling.Drive scientific questions and ideas that support clinical hypothesis generation and program management opportunities that generate value.Serve as a resource for the Product Team, in the analysis and framing of medical and scientific data.Mentor and support development of a matrixed team of Study Physicians and Scientist Directors.Essential Qualifications:Life Science-based degree at masters or above (i.E. M.D., PHD, PharmD, Masters in Life Science-based area).Expertise in Lung Cancer.Significant (> 7 years) clinical development expertise in study design, protocol development, monitoring and implementing clinical trials, interpreting and reporting trial results



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