Location: Barcelona, Spain (On-site) / 3 days working at the office and 2 days working from home.
Join our dynamic and diverse Vaccines and Immune Therapies team at AstraZeneca as a Global Development Medical Director. In this role, you will be an integral part of the Global Study Team (GST), working cross-functionally to provide clinical support for the development, design, and implementation of AstraZeneca-sponsored clinical studies. You will ensure that all clinical studies operate to the highest ethical and safety standards, in compliance with FDA, EMEA, ICH, and GCP guidelines.
Accountabilities: As a Global Development Medical Director, you will be a study physician responsible for the design and conduct of Phase 1, 2, or 3 clinical studies. In this role, you will provide expert clinical input into the design of the clinical studies by writing concept documents and protocols as well as other study documents such as the Investigator's Brochure, supporting internal governance approvals, executing the clinical studies, and ensuring the risk-benefit of a clinical study. Additionally, you will support health authority interactions and briefing documents, lead study level safety reviews, contribute to the development and delivery of the Investigator Brochure and monitor training (e.g., Investigators Meeting), medical/safety, coding, protocol deviation reviews, and support the development and delivery of the clinical study report. You will be accountable for the clinical and scientific leadership and integrity of the studies.
Essential Skills/Experience: M.D degree or equivalent with prior experience in clinical training in infectious disease or vaccinology.
Some industry experience in drug development required, especially in vaccines or monoclonal antibodies for infectious diseases, and with an ability to grow and maintain a high level of expertise in these areas.
Demonstrated past experience in the undertaking of the planning, and timely organization of components of the clinical development plan and work with other functions to achieve successful study initiation and execution.
Ability to drive and write protocols, clinical study reports, and other study documents.
Previous experience in FDA, EMA, and/or other major health authority experience responding to questions and preparing briefing documents (e.g., pre-IND, End of Phase 2, pre-BLA submissions meetings).
Possesses detailed knowledge of Good Clinical Practice (GCP) and other regulations governing clinical research.
Possesses knowledge of medical monitoring, regulatory approval process; pharmaceutical industry/R&D; operations.
Conducts medical oversight activities of third-party vendors where clinical/medical responsibilities have been outsourced, including providing input and guidance on third party documentation to ensure data integrity and protocol compliance.
#J-18808-Ljbffr