Global Clinical Development Senior Medical Director, Infectious Disease/Pulmonology

Job Title: Senior Medical Director, Global Clinical Development (Infectious Disease/Pulmonology) 

Hybrid role: 3 days per week in the office

Location: Gaithersburg

Are you a clinical research expert 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 Senior Medical Director, you will have a unique opportunity to further elevate the Infectious Disease Therapy Area with your pulmonology expertise in one of the world’s most respected biopharmaceutical companies.  The role holds a significant development opportunity for the successful candidate whilst contributing to the positive journey that AstraZeneca is on. 

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., me