Cardiosense is a digital health company that operates at the intersection of wearable technology and artificial intelligence to improve patient health. Our mission is to use physiological waveform data to predict cardiac illness and enable early interventions so people can enjoy healthier, longer lives.
To achieve our mission we are building a physiological waveform AI platform to develop predictive biomarkers to detect and manage cardiac disease. The company has developed a suite of novel digital tools, multi-sensor devices, and analysis algorithms for use by care providers to detect clinical worsening earlier, inform personalized therapy, and improve patient outcomes.
Our team brings together experts in data science, electronics, and healthcare and has partnered with leading healthcare and academic institutions to introduce the next generation of patient waveform monitoring and analytics solutions.
What you'll be doing:
- Build out and manage clinical research and regulatory team across multiple strategic and operational functions
- Own design and execution of research and validation studies for Cardiosense’s machine learning algorithms in collaboration with engineering team and scientific advisory board and in accordance with institutional, GCP, regulatory, and compliance requirements
- Track budget, milestones, and deliverables related to all clinical operation activities
- Own development of study protocols, software requirements, clinical operations SOPs, design documentation, test plans in alignment AI team’s technical needs
- Design and oversee implementation of end-to-end study infrastructure and tools to collect and monitor device data
- Manage relationships with study partners, internal research teams, external CROs, regulatory consultants, and academic institutions
- Prepare and present statistical analysis of algorithm performance at academic and medical conferences
- Assist in the preparation and submission of clinical protocols, FDA clearance and other documents (e.g., IRB/ethics committees, QMS)
- Assist in the activities related to clinical research including, but not limited to site identification, training of investigators and clinical site personnel, and review of data
- Plan and lead interactions with the FDA and other regulatory agencies
- Participate and engage in thought leadership working groups around the regulation of AI in clinical practice
What we're looking for:
- Deep understanding of medical, scientific, or clinical research techniques and principles
- Advanced degree (Ph.D or MD) or relevant experience preferred
- 5+ years of technical, hands-on experience in design, execution, and interpretation of clinical trials, in particular involving digital health and/or devices
- Experience in full-cycle development of clinical algorithms from model training to regulatory clearance highly preferred
- Experience working with cardiology departments and cath labs highly preferred
- Proficient in planning, executing, and reporting health research studies
- Consistent track record of handling and prioritizing multiple studies
- Knowledge and understanding of FDA/relevant local regulations, ICH guidelines, and GCPs
- Able to rapidly acquire familiarity with emerging technologies and software algorithms
- Standout colleague with effective communication and interpersonal skills
- Able to independently author research protocols and drive progress on deliverables in a dynamic environment with changing requirements
- Startup experience preferred
Location and Travel:
- Candidates located in or willing to relocate to the Chicago, IL area are preferred, however other locations will also be considered
- This position may require 20% travel depending on candidate’s location.
Cardiosense is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, ethnicity, religion, disability status, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.