Product Manager, Digital Biomarkers

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 that 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 (CMO) and Clinical to ensure every endpoint reflects clinical reality and answers a real question for cardiovascular trials. Partner closely with the Product Manager for AI, Real‑World Data & Advanced Analytics so the endpoints you define and the platform they build fit together cleanly—shared data, no duplicated effort, clear ownership. Engage directly with trial sponsors to understand their endpoint needs and bring that voice back into the roadmap. Collaborate with Quality and Regulatory to ensure data collection and endpoint delivery meet the standards expected in regulated trial environments (e.g., HIPAA, 21 CFR Part 11, GxP). Why Prolaio? Impactful Work: You will join in the fight against heart failure (HF) and hypertrophic cardiomyopathy (HCM) with the goal of extending and saving the lives of our patients while also being at the forefront of changing the healthcare industry through technology. Innovative Environment: You will be part of an organization doing something that’s never been done before. Professional Growth: You will join a growing team and have a substantial impact on our daily and future operations with the opportunity to continuously learn and grow. Collaborative Team: You will be part of a team of collaborative, curious, and committed individuals focused on the collective good, inclusiveness, scientific excellence, and advancing digital health for cardiology. Who You Are? 8+ years in product management, clinical science, or endpoint/measurement roles in Digital Health, MedTech, or Life Sciences. Deep familiarity with clinical trial endpoints across modalities—digital measures, wearable and sensor data, lab‑based biomarkers, and ePRO/eCOA. Hands‑on experience taking a measure or biomarker from concept through fit‑for‑purpose validation. Working knowledge of the regulatory bar for endpoints (FDA/EMA, biomarker qualification, validation frameworks such as DiMe V3). Excellent communication skills, with a knack for turning scientific and regulatory rigor into clear product decisions. Why You’ll Love Working Here Meaningful Compensation : Competitive salary, performance bonus, and equity so you can share in what we build. Great Health Coverage : Medical, dental, and vision plans with multiple options and strong company contributions. Flexible Spending Perks : HSA, FSA, commuter benefits, and a $1,200 annual Lifestyle Spending Account to support wellness, commuting, family needs, and more. Time to Recharge : Generous paid time off, sick leave, and company holidays. Family‑First Benefits : Paid parental leave, caregiver leave, and support for growing families. Security & Peace of Mind : Company‑paid life insurance and short‑and‑long‑term disability coverage. Plan for the Future : 401(k) plan to help you build long‑term financial security. Care When You Need It : Easy access to telehealth and optional supplemental coverage for life’s unexpected moments. Starting Salary is at $159,000.00 (Exact Compensation may vary based on skills, experience, and location). We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status. #J-18808-Ljbffr Prolaio