Global Development Medical Director

Company: AstraZeneca GmbH
Location: Boston
Posted on: January 26, 2025

Job Description:

As a Global Development Medical Director, you will support the clinical project team and assist the Global Clinical Project Leader (GCPL) and Global Clinical Head (GCH) with the design and interpretation process, establishing clear design objectives for clinical programs and studies. Provide medical input into the content of core labelling texts and medical support for commercial activities. Support medical monitoring of clinical studies. You will also provide medical and scientific expertise as well as tactical and strategic medical input to the development of AstraZeneca's compounds; primarily from Phase IIb to Phase IV. This includes but is not limited to the design, delivery, and interpretation of pivotal clinical trials and studies that further characterize the overall benefit, risk, and value of Respiratory and Immunology products in late-stage development.In this role, you will work in a truly international environment, meet and discuss with key external experts, experts in basic science, as well as commercial and regulatory functions. Our therapy area-aligned groups of physicians and scientists provide clinical guidance and scientific leadership for clinical development programs within AstraZeneca's organization. The Global Development Medical Director will work in a wide range of aspects in pharmaceutical medicine, including contacts with health authorities, colleagues, and marketing companies within AstraZeneca. This is an opportunity to take on the challenges of clinical development in a group of positive, focused, and highly motivated colleagues.Key Responsibilities:

• Provide medical and scientific leadership in the global development of new medicines targeted at indications in the field of respiratory diseases and a wider range of immunological disorders.
• Provide medical and scientific leadership in the innovative design, execution, and interpretation of clinical trials in one or more development programs.
• Build positive relationships with a network of external experts.
• Work closely with Patient Safety, Regulatory Affairs, and Clinical Operations.
• Collaborate with colleagues supporting Early R&I programs and with medical affairs.
• Lead and contribute to medical monitoring of trials.
• Provide expert medical input into the preparation of regulatory documents and interactions with regulatory authorities.
• Provide expert medical and scientific analysis and interpretation of data from ongoing studies and in the literature.
• Develop and review protocols, informed consent, investigator's brochure, and other clinical development documents.
• Participate in the preparation of scientific publications and presentations at scientific meetings and congresses.Basic Qualifications:
• MD or MD/PhD with at least two years of experience in academia or pharmaceutical industry. Late-stage clinical drug development experience preferred.
• Understanding of clinical trials methodology.
• Experience in the design, execution, and interpretation of Late Stage clinical trials.
• Teamwork and collaboration skills.
• Strong verbal and written communication skills.
• Able to travel nationally and internationally.Preferred Qualifications:
• Immunology, Rheumatology, Allergy, or Dermatology background is desirable.At AstraZeneca, we are driven by a shared purpose to push the boundaries of science to deliver life-changing medicines. Our dynamic environment fosters innovation, collaboration, and continuous learning. Here, you'll work alongside some of the brightest minds in the industry, contributing to groundbreaking research that has the potential to impact millions of lives worldwide.Ready to make a difference? Apply now to join our team!
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Keywords: AstraZeneca GmbH, Newton , Global Development Medical Director, Executive , Boston, Massachusetts