Clinical Science Lead

Key Skills

Aartificial intelligence, Algorithms, Biostatistics, Data science techniques, Design, Effective communication skills, Leadership Skill, Machine learning techniques

Job Description

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.

As the Clinical Science Lead, you will lead the design and deployment of a comprehensive clinical strategy to guide development and validation of our noninvasive hemodynamic algorithms.

What you'll be doing:

• Provide design inputs, requirements, and guide implementation of clinical study tools to collect and monitor device data
• Develop statistical analysis plan(s) in collaboration with data science team and physicians for validation studies and present to advisory board
• Lead risk-benefit analysis for determining algorithm performance benchmarks
• Author scientific and medical manuscripts for publication in journals and presentation at conferences
• Own development of study protocols, software requirements, clinical operations SOPs, design documentation, test plans in alignment AI team’s technical needs
• Participate and engage in thought leadership working groups around the regulation of AI in clinical practice
• Track budget, milestones, and deliverables related to all clinical operation activities
• Manage relations in design and execution of research and validation studies (Study Protocol) for our machine learning algorithms in collaboration with our data science team and clinical advisory board
• Lead guidance and communication with study partners, internal research teams, external CROs, regulatory consultants, and academic institutions

What we're looking for:

• MD or Ph.D degree in life sciences or engineering-related field or equivalent experience
• Deep understanding of medical, scientific, or clinical research techniques and principles
• Experience in biostatistics, machine learning, and data science
• 5+ years of technical, hands-on experience in design, execution, and interpretation of clinical trials, in particular involving machine learning algorithms
• 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

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 10-20% 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.