Global Development Medical Director, Late Oncology

hace 2 meses

Barcelona, España Astrazeneca A tiempo completo

.Global Development Medical Director, Late OncologyThe Global Development Medical Director is an important part of the Clinical Project Team (CPT) and Global Study Team (GST). Accountabilities include clinical support for the development and implementation of late phase AstraZeneca sponsored clinical program strategies, including providing clinical input into design & implementation of clinical trials and their delivery, clinical data review, interpretation of results, and activities required for worldwide registration of the product. The role plays a critical role in the medical monitoring of a clinical study ensuring safety to patients. You will work collaboratively with the Global Development Scientists in the clinical aspects underpinning a product.As a Global Development Medical Director in Late Phase Oncology R&D you will:Be responsible for ensuring the risk-benefit of a clinical study, ensuring that all clinical studies operate to the highest ethical and safety standards and in compliance regulatory guidelines and contribute to medical review and monitoring activities.Work cross functionally within clinical product teams to ensure the clinical strategy is translated into the development of the study concept document, study protocol and related documents.Develop relationships with appropriate consultants and key external experts (KEE), study sites, and use these relationships to obtain feedback on protocol design, as well as study training, study execution, and interpretation of study results, and inform recruitment strategies.Be responsible for the relevance and accuracy of clinical science underpinning of clinical study based on detailed scientific review and consultation.Support or lead interactions with global medical affairs, marketing companies, commercial, and regulatory functions in collaboration with GCH/GCPL to ensure cross functional input into protocols.To be successful, you will need to demonstrate capability in the following technical areas:Drug Development/Clinical Development Planning: Demonstrates the ability to undertake the planning, and timely organization of components of the clinical development plan and work with other functions to achieve successful study initiation and execution.Research: Demonstrates understanding of methodology in the design, conduct, review and interpretation, and presentation of clinical research and can conduct literature reviews to inform protocols, and author background sections on the disease or current medical therapy.Presentation and Communication: Ability to prepare and present clinical data, training sessions to internal and external audiences and to contribute to clinical reports and integrated summary reports. Ability to clearly communicate scientific concepts/data to leadership committees (e.G., LSPC, DRC, PRC) or external groups (e.G., Investigator Meetings, IDMCs, Conferences Presentations.)Required Qualifications:Required M.D or MD./Ph.D. degree or equivalent

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    hace 2 meses

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