VP of Scientific and Medical Affairs

Spectral AI is seeking a visionary Vice President, Scientific and Medical Affairs (VP, S&MA) to lead the technological strategy and innovation for the Company's cutting-edge medical devices. In this pivotal role, you will lead a multidisciplinary clinical research team, driving the development and implementation of next-generation Spectral AI imaging and AI platforms, along with the advanced intelligence that powers them. Your leadership will be crucial in shaping groundbreaking innovations that revolutionize the treatment landscape for patients suffering from severe burns and other critical wounds, transforming patient care.

Essential Duties and Responsibilities:

• Lead and mentor a diverse team of research scientists, statisticians, and medical writers in the design and execution of randomized controlled trials (RCTs) and data generation processes, ensuring scientific rigor and alignment with regulatory standards.
• Develop and manage Key Opinion Leader relationships across wound care specialties with a focus toward market development and maintenance.
• Oversee the Scientific and Medical Affairs team, fostering close collaboration with cross-functional departments, including Research and Development, Commercial, Quality, Biomedical Engineering, Project Management, and Manufacturing, to drive seamless integration of clinical insights into product development and commercialization.
• Develop and implement a robust publication strategy, leading the authorship and presentation of scientific papers and reports related to clinical trial design and outcomes in diagnostic imaging technologies for wound care and AI-driven devices.

• Engage and build strong relationships with external stakeholders, including physician leaders, study investigators, and key opinion leaders, to advance clinical and scientific objectives.

• Collaborate closely with Regulatory Affairs to achieve business objectives, aligning clinical strategies with Commercial goals, while emphasizing customer needs, market access, and reimbursement pathways.
• Advise the executive leadership team on a wide range of technological, strategic, and policy issues related to AI and wound assessment, ensuring alignment with the company's vision and innovation roadmap.

• Perform other duties as assigned

Qualifications:

Required education and experience:

• PhD in a relevant field or related discipline of biomedical engineering, machine learning, statistics, computer science etc., or MS degree with equivalent clinical research experience
• 10+ years of relevant medical device industry or academic experience
• Experience leading research projects with multiple stakeholders

Knowledge, Skills, and Abilities:

• Demonstrated experience in AI research and development, including 5+ years in technical or scientific team leadership.
• Proven expertise in designing and leading large-scale AI platforms from concept to production, with multiple successful releases.
• Skilled in developing and executing publication strategies, including preparing abstracts, posters, and manuscripts for peer-reviewed journals, and presenting at medical conferences.
• Demonstrated ability to lead diverse teams of clinical researchers, statisticians, and medical writers.
• Proven experience in applying computer vision techniques, with a focus on medical imaging, in clinical environments.
• Extensive experience in clinical study protocol development, analysis, and regulatory compliance including Good Clinical Practice and Clinical Trials (21 CFR Parts 50, 54, 56 and 812).
• Strong record of accomplishment in applying machine learning and AI tools to medical, biological, or healthcare datasets.
• Deep proficiency in basic statistics and experimental design, with experience interpreting complex data sets.
• Familiarity with open-source machine learning frameworks (e.g., PyTorch, TensorFlow) and languages (R, Python, C++).
• Skilled in navigating fast-paced, high-pressure environments with results-oriented oversight.
• On-site leadership at the Dallas headquarters required (this is not a remote role).

Bonus Qualifications:

• Success developing and submitting PMA/510(k)/De Novo regulated medical devices
• Working knowledge of Artificial Neural Networks (ANNs), especially Convolutional Neural Networks (CNNs) and high-dimensional data sets

Successful candidates will have:

• Ability to adapt in a changing, fast-paced environment
• Strong interpersonal and teamwork skills
• Excellent verbal and written communication skills for conveying scientific and clinical data to non-expert audiences and internal stakeholders
• Patience to handle complex situations, while being clear with team in setting and meeting aggressive time schedules

Physical Requirements:

The physical demands described below are representative of those that must be met by an individual to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Prolonged periods of sitting at a desk and working with a computer.

Travel:

5 - 10% travel time expected

Equal Employment Opportunity:

Spectral AI is an equal opportunity and affirmative action employer. All applicants will be considered for employment without regard to race, color, ancestry, national origin, sex, gender, sexual orientation, marital status, religion, age, disability, gender identity, results of genetic testing, protected veteran status, or any other characteristic protected by applicable federal, state, or local laws.