Product Manager, Digital Biomarkers
Who Are We? Prolaio believes that continuous learning and collaboration can make a significant difference in how heart care is administered. We are creating smarter ways to address heart disease and heart risks by uniting patients, care teams, and researchers on a secure, technology-enabled platform that drives clinical innovation and offers a path towards better patient outcomes. This is precision cardiology, and we know it’s within reach. What Will You Do? The Overview The Product Manager will own the clinical endpoints our platform enables for trial sponsors—the full menu of measurements we can collect or deliver in support of proving a cardiovascular drug is safe and effective. You will decide what we measure and how we prove it holds up: the data we collect from medical devices and wearable sensors, the digital biomarkers we build on top of that data, the lab-based biomarkers, ePRO/eCOA measures, and other assessments that can serve as endpoints in a cardiovascular trial. The Specifics Own the full menu of clinical endpoints our platform offers sponsors—digital measures, lab-based biomarkers, ePRO/eCOA, and beyond. Decide what we build, what we buy, and what we partner for, anchored in real sponsor and therapeutic-area need. Maintain a clear, prioritized endpoint roadmap, sequencing investments by clinical impact, sponsor demand, and feasibility. Track the evolving endpoint landscape—new digital biomarkers, novel sensors, and shifting regulatory expectations—and translate it into where we place our bets. Define what data we collect and from which medical devices and wearable sensors, weighing signal fidelity, patient burden, and fitness for the question at hand. Evaluate and select sensor and device partners, setting the bar for data quality, interoperability, and regulatory readiness. Define the raw data we capture and retain so that today’s collection supports tomorrow’s biomarkers and endpoints, not just the trial in front of us. Partner with Data Science and Clinical to turn raw device and sensor signals into meaningful digital biomarkers, owning the use case, the target population, and the measure’s intended claim Write clear requirements for new biomarkers and guide them from concept through prototype, pilot, and trial-ready measure. Curate the wider endpoint set alongside digital biomarkers—lab-based biomarkers, ePRO/eCOA, and other functional assessments Own the fit-for-purpose case for each endpoint, working with Clinical, Data Science, and Regulatory through verification, analytical validation, and clinical validation (e.g., the DiMe V3 framework). Stay close to the regulatory bar for endpoints—FDA and EMA expectations, biomarker qualification pathways, and ePRO/eCOA standards—and build the evidence so our endpoints stand up to sponsor and agency scrutiny. Translate dense scientific and regulatory requirements into clear, buildable specs for the teams developing and delivering each measure. Work with the Chief Medical Officer (C...