Global Development Medical Director, Respiratory and Immunology Location options: Gaithersburg, MD (US), Warsaw, Poland, Barcelona, Spain
As a Global Development Medical Director, you will support the clinical project team and assist the Global Clinical Project Leader and Global Clinical Head with the design & interpretation process, establishing clear design objectives for clinical programs and studies.
You will provide medical input into the content of core labelling texts and medical support for commercial activities.
You will provide support for 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 of studies that further characterize the overall benefit and risk and value of Respiratory and Immunology products in late-stage development.
In the BioPharmaceuticals Research & Development, Late-stage Development, Respiratory & Immunology (R&I;) function 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.
What you will do: 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 strong relationships with a network of external scientific experts.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) clinical programs but will collaborate with colleagues supporting Early (R&I;) stage programs as well as medical affairs colleagues.Lead and contribute to medical monitoring of trials.Provide expert medical input into the preparation of regulatory documents and interactions with regulatory authorities.
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