Position overview:

The Chief Medical Officer (CMO) will play a pivotal role as the Company’s primary clinical leader, serving as the external face of its medical and clinical vision. The CMO will engage with key stakeholders, including customers, key opinion leaders (KOLs), partners, investors, research institutions, patient advocacy groups, and other strategic constituents. By understanding and addressing the needs of these stakeholders, the CMO will help develop actionable clinical research and business strategies, objectives, and plans that align with the Company’s short- and long-term goals.

As the clinical strategist for a groundbreaking open-source medical device company, the CMO will guide the advancement of innovative products in low-intensity focused ultrasound (LIFU) therapeutics and near-infrared (NIR) diagnostic platforms, ensuring they meet the widest set of global clinical needs while adhering to the relevant international regulatory standards. This role combines visionary leadership with hands-on collaboration to drive innovation, accessibility, and impact in healthcare technology.

• Collaborate with research partners to design clinical trials to (i) validate the efficacy and safety of the Company’s open source medical devices; and (ii) use the Company’s medical devices in novel applications across a variety of indications.
• Collaborate with external partners to design research and commercialization programs that advance science and deliver breakthrough solutions to  patients while creating value for partners, the Company, and the greater community.
• Foster relationships with principal investigators, clinical research organizations (CROs), regulatory bodies (FDA/EMA), and key stakeholders.
• Participate in business discussions on behalf of the Company as the key clinical and regulatory subject matter expert.
• Lead clinical efforts, ensuring scientific rigor in all Company-sponsored studies,  publications, and presentations.
• Develop and execute training plans for clinicians and staff on proper device and platform use.
• Stay informed on industry advancements, ensuring the Company remains at the forefront of research and clinical development.

• Provide clinical and regulatory input to define product specifications to fit target indications and overall clinical and regulatory strategy.
• Gather and incorporate perspective from the end users (i.e. clinicians) into product strategy.
• Analyze data from the Company’s products to determine quality and effectiveness.

• Define clinical requirements that drive product specifications and clinical pathways for LIFU and NIR devices, ensuring alignment with FDA, EMA, and other regulatory agency requirements.
• Design global regulatory strategies that anticipate hurdles for open-source devices, including risk classification and technical documentation.
• Act as the primary liaison for clinical and regulatory programs in interactions with regulatory agencies and partners.

• Represent the Company and speak at scientific and medical conferences, leveraging expertise in therapeutic ultrasound and/or biophotonics to advance market adoption.
• Build partnerships with research hospitals, patient advocacy groups, and academic institutions to align product development with unmet clinical needs.
• Partner with the commercial team to promote sales of the Company’s products and solutions.

Required Skills & Experience

• Minimum of 10 years of experience in a senior clinical development leadership position in therapeutic ultrasound and/or photonics. 
• M.D. and or Ph.D., as well as broad clinical expertise in therapeutic ultrasound and/or photonics.
• Proven success in FDA/EMA submissions (510(k), PMA) and navigating the global regulatory landscape.
• Experience in business development or commercialization of innovative technologies.
• Clinical research expertise, with ability to steer research from benchtop testing through pre-clinical, feasibility, and pivotal studies in populations of interest.
• Track record of advancing novel technologies from concept to market, including AI-driven diagnostics.
• Willingness to travel to professional meetings and meet customers and stakeholders around the world.

• Strong communication skills for articulating complex concepts to both technical and non-technical audiences.
• Ability to bridge the gap between clinical practice and technological development.
• Commitment to open source principles and collaborative innovation.
• Strong ethical foundation and dedication to patient safety and care quality.
• Intelligence, trustworthiness, creativity, dedication, and entrepreneurial spirit.