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 immunological product development and regulatory approvals in line with the target product profile. You will 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 Immunology products in late-stage development. You will also be medical monitors of the clinical studies and support the study teams from a medical and scientific perspective. The position will be based in Barcelona or Warsaw preferred.
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.
Typical Accountabilities Providing medical and scientific leadership in the global development of new medicines targeted at indications in the field of immunological disorders.
Providing medical and scientific leadership in the innovative design, execution, and interpretation of clinical trials in one or more development programmes.
Building strong relationships with a network of external scientific experts.
Working closely with colleagues in other functions including Patient Safety, Regulatory Affairs, and Clinical Operations.
Involvement in late stage (Ph2b and later) Immunological clinical programmes while collaborating with clinical colleagues supporting Early (R&I) stage programs as well as medical affairs colleagues.
Leading and contributing to medical monitoring of trials.
Providing expert medical input into the preparation of regulatory documents and interactions with regulatory authorities.
Providing expert medical and scientific analysis and interpretation of data from ongoing studies and in the literature.
Developing and reviewing protocols, informed consent, investigator's brochure, and other clinical development documents.
Participating in the preparation of scientific publications and presentations at scientific meetings and congresses.
Education, Qualifications, Skills and Experience Essential: Fully qualified physician (MD or MD PhD) with experience in late stage Immunology clinical drug development from pharma industry or academia.
Good understanding of clinical trials methodology.
Experience in the design, execution, and interpretation of Late Stage clinical trials in the respiratory area or any other therapeutic area/specialty in clinical development.
Good teamwork and collaboration skills.
Good verbal and written communication skills in English.
Able to travel nationally and internationally.
Desirable: Rheumatologist, Immunologist.
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