AstraZeneca
Global Development Medical Director
AstraZeneca, Gaithersburg, MD
Global Development Medical Director, Respiratory and ImmunologyLocation options: Gaithersburg, MD (US), Warsaw, Poland, Barcelona, SpainAs 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 wider range of immunological disordersProvide 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 trialsProvide 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 QualificationsMD or MD PhD with minimum of 1 year of clinical experience or experience in drug developmentUnderstanding of clinical trials methodologyCollaboration skillsExcellent verbal and written communication skills in EnglishAbility to travel nationally and internationallyPreferred QualificationsPulmonary medicine, Immunology, Rheumatology, Allergy, or Dermatology background is desirable.Experience in the design, execution and interpretation of Late Stage clinical trialsWhen 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.The annual base salary for this position ranges from $233,290 - $349.935. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program. Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. 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.Date Posted04-Dec-2024Closing DateOur mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.SummaryLocation: US - Gaithersburg - MD; Poland - Warsaw; Spain - BarcelonaType: Full time