Chief Medical Safety Officer; VP, Clinical Oversight & Innovation

Boldly innovating to create trusted solutions that detect, predict, and prevent disease.Discover your power to innovate while making a difference in patients' lives. iRhythm is advancing cardiac care...Join Us Now! At iRhythm, we are dedicated, self-motivated, and driven to do the right thing for our patients, clinicians, and coworkers. Our leadership is focused and committed to iRhythm's employees and the mission of the company. We are better together, embrace change and help one another. We are Thinking Bigger and Moving Faster.About This RoleThe Chief Medical Safety Officer; VP, Clinical Oversight & Innovation will be a key leadership role reporting directly to the Chief Medical Officer, who is also the Chief Scientific Officer and EVP of Product Innovation. This position will be responsible for providing comprehensive medical oversight across all company functions, with a particular focus on medical safety, regulatory affairs, and quality assurance.The individual will oversee medical safety across all company functions, with an emphasis on regulatory and product, while also assuming leadership roles in scientific research, clinical innovation, and as a Senior Medical Director of the Independent Diagnostic Testing Facility (IDTF)As Senior Medical Director of the IDTF, the individual will work to ensure clinical excellence, safety, and regulatory compliance in IDTF services including clinical oversight of the long-term continuous monitoring and mobile cardiac telemetry services. The individual will also supervise the other IDTF site medical directors.This expanded role not only covers the safety and regulatory aspects but also integrates medical leadership across clinical operations, clinical research, scientific affairs, and other operational functions of the company.Key Responsibilities:Medical Safety Oversight: Ensure comprehensive medical safety governance from product design to post-market surveillance. Working closely with the VP of Quality, will oversee adverse event monitoring, analysis, and safety reporting. Collaborate with Quality Affairs and Regulatory Affairs to ensure compliance with regulations and industry standards.Medical Directorship: Serve as the senior medical director of the IDTF, providing clinical supervision and oversight of ambulatory cardiac monitoring services, including long-term continuous monitoring and mobile cardiac telemetry, and of the site-based IDTF directors, who will report to the individual. Ensure compliance with all regulatory, payer, and clinical requirements for IDTFs, including supervision of diagnostic tests and quality control measures in partnership with the Senior Vice President of Clinical Operations.Clinical Oversight and Innovation: Provide medical expertise and guidance throughout the product lifecycle (design, clearance, commercialization, post-market surveillance, lifecycle management). Participate in pre-submission meetings with regulatory bodies and contribute to regulatory submissions. Collaborate with Product Management, Product Development, and Systems Development to provide medical input on new product development and enhancements. Serve as a final approver, shared with the CMO, of all clinical and medical decisions touching product, service, labeling, and related organizational functions.Scientific Leadership: Support the Scientific Affairs function to guide real-world evidence studies and clinical research initiatives. Contribute to the design and interpretation of observational data, clinical trials, data science, and new product innovation studies, functioning as an internal principal or collaborating investigator. Represent the company at scientific conferences and engage with key opinion leaders in the field of cardiology and digital health.Cross-functional Collaboration: Along with the CMO, work closely with Medical Affairs, Commercial, Product Marketing, Corporate Strategy, Regulatory Affairs, Quality Affairs, and other teams to fully integrate medical perspectives. Work with Medical Affairs and Sales Enablement for clinical knowledge dissemination, development of medical claims, and creation of digital content. Serve as a medical liaison between the company and external stakeholders, including healthcare providers, regulatory agencies, and industry partners.Qualifications:MD or equivalent medical degree with subspecialty board certification in in cardiac electrophysiology or cardiology. Ongoing or recent medical practice is strongly preferred.Active medical licenseMinimum 15 years combined years of experience in clinical practice, academic medicine, and medical device industry, with a focus on cardiovascular diagnostics and digital healthStrong understanding of FDA regulations and regulated products in cardiovascular disease including hardware, software as medical device, and AI technologiesExperience in ambulatory ECG IDTF operations and clinical workflow of ambulatory cardiac monitoringExpertise in AI and machine learning applications