Vice President of Clinical Development and Regulatory Processes at Lung Biotechnology PBC and Lung Bioengineering Inc (subsidiaries of United Therapeutics Corporation)
Aimee Smart is an accomplished senior executive with more than 20 years of success in the pharmaceutical and biotechnology industries, Aimee enjoys leading deeply challenging projects where there is no clear path forward. She understands how to work with many people across various functions, operate under high pressure, and meet critical timelines to deliver results. And because everything she does in regulatory strategy, designing, and running clinical development programs is years in the making, her complex problem-solving ability includes considering the world of today while anticipating what might happen in the future.
In her current role of Vice President of Clinical Development and Regulatory Processes at LungBiotechnology PBC and Lung Bioengineering Inc (subsidiaries of United TherapeuticsCorporation), Aimee reports directly to the parent company CEO, driving clinical drug development and leading a multifunctional organization and a geographically dispersed team of ver 60 professionals, covering all aspects of development including; regulatory affairs, quality assurance, clinical development, product development, clinical supply, clinical operations, biostatistics and data management, and project management.
Aimee is part of the executive leadership team of United Therapeutics Corporation, representing her companies needs at the corporate level. She was responsible for Lung Biotechnology’sreorganization and setting its new strategic goals. And after leading the successful turnaround of the underperforming subsidiary to a respected, productive company, Aimee’s CEO asked he rto do it a second time and lead the Lung Bioengineering subsidiary.
During her more than 14-year tenure at Lung Biotechnology PBC, Aimee has served in increasingly senior clinical development, regulatory affairs and quality roles, including as Associate Vice President and Head of Office and Director, Global Regulatory Affairs. Her experience also includes regulatory affairs posts at VIRxSYS Corporation, Human GenomeSciences, Nabi Biopharmaceuticals, and Cato Research.
As much as she enjoys solving complex problems and driving results, Aimee is most passionate about ensuring that what she is doing is connected back to a meaningful mission that directly impacts people’s lives in a positive way.
Aimee earned her Bachelor of Science in Microbiology from North Carolina State University, where she was later honored with its Outstanding Young Alumni award. She completed her executive MBA from the University of Maryland in 2022 and was named one of the Best and brightest EMBA students by Poets & Quants magazine. In addition, Aimee holds certifications in Leadership Coaching for Organizational Performance from American University and in Regulatory Affairs for the U.S. and Europe from the Regulatory Affairs Professional Society.
She maintains professional memberships in the Drug Information Association, RegulatoryAffairs Professional Society, Women in Bio, and International Coach Federation. She also serves as a Member for the NCSU College of Sciences Foundations Board.
