Amanda McEwen
SVP, Clinical Development & Regulatory Affairs | Executive Fellow, Harvard Business School | Adjunct Lecturer, Northeastern University | Independent Biotech Advisory Board Member
- Role
- SVP, Clinical Development at Salubris Biotherapeutics
- Location
- Boston, MA, US
- LinkedIn followers
- 500 followers
About Amanda McEwen
I specialize in cultivating the purposeful growth of Clinical Development & Regulatory Affairs capabilities to drive biotech corporate strategy. I have a proven track record of accelerating and de-risking Clinical Development milestones and leading successful Regulatory interactions. Some highlights of my career thus far have been the pivotal roles I played in bringing two novel therapeutics to market: Inbrija® a novel dry powder inhalation therapy to treat motor issues in Parkinson’s patients, approved by the FDA and EMA; and Rivfloza® just the second product for the treatment of Primary Hyperoxaluria, approved by the FDA. My expertise spans the entire Clinical Development lifecycle from early translational stages (initial IND) through product registration (NDA/BLA & MAA dossiers). My therapeutic area experience includes a diverse spectrum of diseases such as rare, neurodegenerative, cardiovascular, respiratory, infectious, metabolic, and oncology. The array of therapeutic product types I have experience with is also broad, and includes both small and large molecule products, including but not limited to ASOs, siRNA, mAbs, recombinant proteins and protein fusions, ADCs, and microbiome products.Much of my success is attributable to my ability to effectively build and manage high performing teams. In my approach to team-building, I place a strong emphasis on mentorship, education, and relentlessly affording team members opportunities for growth and visibility. In addition to my work in biotech, I am an adjunct lecturer in the Master of Science in Regulatory Affairs program at Northeastern University and a recurring Guest Lecturer and case writer for the Entrepreneurship in Life Sciences course at Harvard Business School.
Experience
SVP, Clinical Development
Jan 2024 — Present
Education
University of York
Master of Research Methods, Psychology
College of the Holy Cross
Bachelor of Arts, Psychology
Bentley University
Doctor of Philosophy - PhD, Business Analytics
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