Global Development Medical Director at AstraZeneca in Gaithersburg, Maryland

Job Description:

Join our dynamic and diverse Vaccines and Immune Therapies team at AstraZeneca as a Global Development Medical Director. In this role, you will be a member 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 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 share your expertise and provide 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, implementing 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.



Essential Skills/Experience

• M.D degree or equivalent with prior experience in clinical training in infectious disease or vaccinology


• Proven 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.


• Proven 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 collaboration 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.

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.


At AstraZeneca, we are committed to making a difference by fusing data and technology with scientific innovations to achieve breakthroughs. Our inclusive environment encourages collaboration across academia, biotech, and industry to build swift impacts on disease. We harness digital tools to fast-forward research from lab to real-world applications. Here, curiosity thrives as we push boundaries to deliver life-changing medicines.


Ready to make a meaningful impact? Apply now!


AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements. Apply Now