Global Clinical Development Medical Director, Infectious Disease

AstraZeneca • Gaithersburg, MD

4d • Hybrid

About The Position

Global Clinical Development Medical Director Hybrid Working: 3 days per week in the office Location: Gaithersburg, MD Are you a clinical research physician ready for new opportunities? Would you like to play a pivotal role in the development of potential medicines? If you are passionate about being a medical leader for a cross-functional team in a group that drives action towards the improvement of global public health– join us! As a Global Clinical Development Medical Director you will have a unique opportunity to further elevate the Infectious Disease franchise in one of the world’s most respected biopharmaceutical companies. The role holds a great development opportunity for the successful candidate whilst contributing to the positive journey that AstraZeneca is on.

Requirements

• Fully qualified physician (MD or MD PhD) with clinical experience in pulmonology
• 1-3 years of experience in clinical drug development, preferably from pharma industry
• Good understanding of clinical trials methodology
• Experience in the design , execution, and interpretation of clinical studies (e.g., medical monitoring, data cleaning , clinical study report writing )
• Excellent teamwork and cross-functional collaboration skills
• Ability to communicate effectively in clinical team settings
• Excellent verbal and written communication skills (including giving presentations) in English
• Must demonstrate high integrity
• Be office based at an AstraZeneca site (Gaithersburg)

Nice To Haves

• Pulmonary expertise in COPD and/or bronchiectasis
• Additional clinical experience in infectious diseases, vaccines, and/ or immunology
• Named Investigator on a several clinical trials
• 1-3 years of pharmaceutical industry knowledge and experience
• Progressed medicines into first time in human Phase 1 , Phase 2 delivery of proof of principle , and Phase 3 pivotal efficacy studies
• Experience with Translational programs moving from preclinical to first in human studies and interpretation of immunological assay results
• Significant and consistent peer-reviewed publication track record

Responsibilities

• Providing medical and scientific leadership in the global development of new medicines targeted at indications in the field of infectious diseases
• Help design, execute, and interpret clinical trials in one or more development programs (Phase 1 through Phase 3)
• Build strong relationships with a network of external scientific specialists and opinion leaders as well as site investigators
• Work closely with colleagues in other internal functions including Patient Safety, Biometrics, Regulatory Affairs, Clinical Operations , and Translational Medicine
• Medical oversight to ensure the safety of study participants including review of Adverse Events of Special Interest and Serious Adverse Events and review and writing of safety narrative reports
• Medical oversight responsibilities for medical activities outsourced to third party vendors
• Provide expert medical input and writing of regulatory documents and interactions/responses with regulatory authorities
• Provide expert medical and scientific analysis and interpretation of data from ongoing studies and in the literature
• Prepare publications and presentations for scientific meetings and congresses

Benefits

• qualified retirement program [401(k) plan]
• paid vacation and holidays
• paid leaves
• health benefits including medical, prescription drug, dental, and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree