Global Development Medical Director- Vaccines and Immune Therapies 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 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, execute 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 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.
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.
Strong leadership and teamwork skills with the ability to influence others, drive consensus building, and present concisely/clearly to upper management stakeholders
Demonstrates a proven ability to both independently complete, and lead peers in completion in components of complex clinical study plans
Strong presentation skills including preparation of clear and concise presentation decks and written material
Ability to leverage relevant and recent methodology in the design, conduct, review and interpretation, and presentation of clinical research.
At AstraZeneca, we are changemakers on the world stage at an exciting frontier of medicine. We are helping to transform healthcare and build pandemic preparedness to protect against future health crises. We are team players who invest in ground-breaking collaborations, local partnerships, and commercial initiatives. Our diversity – in culture, language, geography, skills and experience – powers us to serve the global populations we seek to develop medicines for. In our inclusive team, we encourage each other to bring our whole-selves to work. Every action we take is to enhance lives. Our work is essential, rewarding, fulfilling, stimulating, and empowering.
We feel real pride knowing we are making a meaningful and lasting difference.
Ready to make a meaningful impact on global health? Apply today to join our team!
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