Product Manager, Clinical Endpoints

Prolaio•Chicago, IL

1d•$159,000

About The Position

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.

Requirements

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

Responsibilities

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).