Global Development Medical Director

3 weeks ago

Independence, United States AstraZeneca Full time

Location (on-site):

Bar celona or Warsaw preferred. 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, implementation, conduct and interpretation of Phase 2b to Phase IV studies to support respiratory product development and regulatory approvals in line with the target product profile. You willprovide 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 of studies that further characterize the overall benefit and risk and value of Respiratory products in late-stage development. You will also be medical monitor of the clinical studies and support the study teams from a medical and scientific perspective. In the BioPharmaceuticals Research & Development, Late-stage Development, Respiratory you will be given the opportunity to work in a truly international working environment, with opportunities to meet and discuss with key external experts, other medical colleagues and 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 global organization. The Global Development Medical Director will work in a wide range of aspects in pharmaceutical medicine, and due to the global responsibilities, there will be a multitude of 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. Typical Accountabilities: In this positionyou will be involved in providing medical and scientific leadership in the global development of new medicines targeted at indications in the field of Respiratory and Cardiovascular disorders. You will have an important role providing medical and scientific leadership in the innovative design, execution and interpretation of clinical trials in one or more development programmes. You will be involved in building strong relationships with a network of external scientific experts. You will work closely with colleagues in other functions including Patient Safety, Regulatory Affairs, and Clinical Operations. You will be involved primarily in late stage (Ph2b and later) Respiratory franchise clinical programmes but will be expected to collaborate with clinical colleagues supporting Early Respiratory stage programs as well as Medical Affairs colleagues. You will lead and contribute to medical monitoring of trials. You will provide expert medical input into the preparation of regulatory documents and interactions with regulatory authorities. You will provide expert medical and scientific analysis and interpretation of data from ongoing studies and in the literature. Develop and review protocols, informed consent forms, investigator’s brochure and other clinical development documents. You will participate in the preparation of scientific publications and presentations at scientific meetings and congresses. Education, Qualifications, Skills and Experience Essential: You are a fully qualified physician (MD or MD PhD) with experience in late/early stage clinical drug development from pharma industry or academia. You have good understanding of clinical trials methodology. You have experience in the design, execution and interpretation of Late Stage clinical trials in the respiratory and/or cardiovascular area; or any other therapeutic area/ specialty in clinical development. You have good teamwork and collaboration skills. You have good verbal and written communication skills in English. You are able to travel nationally and internationally. Desirable: Respiratory and/or Cardiovascular clinical drug development experience from pharma industry or academia, or proven broad experience across other therapeutic areas in clinical development. Strong clinical research experience, particularly in Late stage Clinical Development.

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