Global Medical Director, Immunology

Global Medical Director, ImmunologyLocation Options : Boston, MA or Gaithersburg, MDAZ’s vision is to grow and expand the indications and assets in Respiratory and Immunology to become a major player in the field.  As a Global Development Medical Director, you will support the clinical project team and assist the Global Clinical Program Lead (GCPL) and Global Clinical Head (GCH) with design, conduct, monitoring, data interpretation and reporting of immunology clinical trials, primarily from Phase IIb to Phase IV.  You will ensure studies are operated according to the highest scientific and ethical standards and in compliance with internal SOPs, local regulations, GCP and regulatory requirements.  You will ensure clinical data collected allow to assess the benefits and risks of the product, as aligned with the overall global strategy of the clinical development program. You will also provide medical and scientific expertise as well as tactical and strategic medical input to the development of AstraZeneca’s products.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 contact 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.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 within the Global Study Team in the innovative design, execution, and interpretation of clinical trials in one or more development programs.Responsible for safety surveillance on a study level with Patient Safety including the process for Adverse Events (AE) / Serious AE reporting.Leads governance interactions in conjunction with or as delegated by the GCPL including Development Review (Advisory) Committees and Protocol Review CommitteesDelivery of clinical, scientific, and medical information / query responses to Regulatory Agencies, Ethic Committees, Marketing Companies (MCs), and investigators / sites, and provides clarifications as well as solves clinical, scientific, and medical issues in the Global Study TeamAccountable to GCPL / GCH (or delegate) for identifying risks and proposing mitigation strategies to deliver successful studiesResponsible for scientific medical content at international investigator meetings, and support local Marketing Companies (MC) for country-level activitiesBuild positive relationships with external experts, academic research organizations and clinical research organizations, as applicableWork closely with Patient Safety, Regulatory Affairs, Clinical Operations and Medical Affairs, and collaborate with colleagues supporting Early R&I programs.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, statistical analysis plans, medical oversight plans, risk management plans, 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 withat 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 internationallyPreferred Qualifications
• Immunology, Rheumatology, Allergy, or Dermatology background is desirable.When 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.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!Date Posted05-Jan-2025Closing Date30-Jan-2025Our 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.SummaryLocation : US - Boston - MA; US - Gaithersburg - MDType : Full time