Sonya Heldman, MBA

- Serve as the primary point of contact for customers to plan, direct, and coordinate clinical research projects and trials at Zephyrx (SaaS health information technology innovator specializing in end-to-end spirometry cloud solutions) - Manage the end-to-end process of participating sites in clinical studies, from preparation to closure - Cultivate and develop key strategic client partnerships to drive growth and success - Keep management informed of industry trends and changes in the clinical research landscape - Prepare for and actively participate in quality assurance audits and protocol revisions - Provide instruction and guidance to research staff and clinicians, focusing on training and procedural aspects of the platform

-Executed six transformational projects: Streamlined device affiliate ownership through an executive summary deck, standardized in vitro diagnostic procedures via ISO 20916 summary, and established consistent device safety reporting practices across markets -Led four critical initiatives, including the development of a live educational presentation for over 300 colleagues on team resources, devised a comprehensive departmental upskilling business strategy, evaluated business priorities, and transformed insights into a persuasive business case detailing benefits, costs, and timelines -Leveraged researched cultural insights to design an impactful deck for 6 international department leaders, prompting a discussion on change resilience and reframing failure as a valuable learning experience

- Educational seminars covering topics such as Design for Manufacturing (DFM), working with manufacturers and suppliers, and quality & testing - Develop a manufacturing roadmap to advance from the current MRL to MRL 8 - Create PRD living document, Bill of Materials (BOM), and Bill of Process (BOP)

Conducted 30+ investigative market research interviews with neurological surgeons, funded by the National Science Foundation (NSF) Innovation Corps (I-Corps) program to explore commercialization potential and develop a comprehensive business model.

Masters in Business Administration, concentrating on Life Science Entrepreneurship (LSE). Coursework included Biomedical Intellectual Property, Commercialization of Biomedical Innovation, and Regulatory Navigation. The MBA LSE program partners the Lally School of Management at Rensselaer and with the Icahn School of Medicine at Mount Sinai.

I earned dual bachelor's degrees in Biomedical Engineering and Design, Innovation, & Society (DIS) My engineering classes focused on building a technical understanding of how electrical, mechanical, and material components exist synergistically in the body. As well as, technologies that contribute to the current standard of care in medicine; medical devices, diagnostics, treatments, and protocols. On the other hand, my design coursework consisted of sequential studios and seminars in which I explored innovative design concepts through visual representations, physical prototypes, and user testing. The DIS program placed a strong emphasis on socially conscious design and exploring the cultural dimensions of design artifacts. The opportunity to formulate design problems that challenged conventional assumptions fundamentally changed my appreciation for creative thought.