Global Clinical Development Senior Medical Director, Infectious Disease/Pulmonology

Accountabilities

• 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) and present the clinical strategy at internal governance meetings
• Lead the Clinical Team and work closely with other colleagues in other internal functions including Patient Safety, Biometrics, Regulatory Affairs, and Clinical Operations
• Build strong relationships with a network of external scientific specialists and opinion leaders
• 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
• Provide expert medical input and write clinical study documents such as protocols, study reports, and regulatory submission documents and responses
• 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

Essential Skills/Experience

• Graduate of a recognized school of medicine with an MD degree or equivalent with board-certification in pulmonology
• Demonstrated clinical research expertise in the field of pulmonology (especially in COPD and bronchiectasis)
• Pharma industry experience in clinical drug development for at least 2.5 years
• Developed/delivered in parallel, composed of multiple complex and large studies (e.g., including but not limited to multinational, pivotal Phase 3 efficacy studies)
• Demonstrated ability to lead the development of a program strategy (e.g., Clinical Development Plans) and be accountable for project plans, timelines, progress, and outcomes
• Experience in the design, execution, and interpretation of clinical studies (e.g., medical monitoring, data cleaning)
• Demonstrated ability leading and motivating teams in a matrix environment
• Demonstrated ability to lead, coach, and mentor physicians and scientists
• Demonstrated ability to lead, coach, and mentor physicians and scientists
• Demonstrated ability to cultivate excellent cross-functional collaborations
• Demonstrated ability to effectively communicate at multiple levels of the organization
• Must demonstrate high integrity
• Organize and deliver Advisory Boards with international Key Opinion Leaders (KOLs)
• Demonstrated AI/digital mindset and experience applying AI-enabled and generative AI tools to support clinical development activities (e.g., data analysis, medical writing, clinical trial operational efficiency)
• Excellent verbal and written communication skills (including giving presentations) in English
• Be office based at the Gaithersburg AstraZeneca site at least 3 days a week