Chief Data & Analytics Officer (CDAO)

Prolaio • Chicago, IL

5d • $234,482

About The Position

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 integrating a connected platform enabled by smart data science to help patients access the care and attention that will inform better treatments and outcomes. We envision a future where care teams and hospitals can be more effective, the healthcare system can be more efficient, and patients have a better care experience and more fulfilling lives. This is precision cardiology, and we know it’s within reach. The Overview Prolaio is seeking a Chief Data & Analytics Officer (CDAO) to serve as the strategic architect of the company’s Cardiac Intelligence platform. This executive leader will be responsible for transforming high-density patient data into actionable clinical and operational insights that advance Prolaio’s mission and growth. Reporting to the General Manager, the CDAO will lead the development and validation of digital biomarkers, operationalize Generative AI (LLM) strategies to accelerate clinical trials, and oversee the integration of real-world data sources, including EMR and claims data. This role is central to translating advanced analytics and AI capabilities into measurable impact across clinical development. The CDAO will act as a critical bridge between Prolaio’s digital platform and Kardigan’s therapeutic pipeline, ensuring that data assets directly support the reduction of drug development timelines and the improvement of patient outcomes. The Specifics Strategic Leadership & Data Governance Define and execute the enterprise data strategy, treating data as a product that drives value for Prolaio’s remote monitoring platform and Kardigan’s therapeutic development. Establish a robust data governance framework to ensure data quality, integrity, and traceability across the entire lifecycle, ensuring readiness for FDA regulatory submissions (21 CFR Part 11). Champion a "data-first" culture by promoting data literacy across clinical, operational, and commercial teams, aligning technical roadmaps with business objectives. Advanced Analytics & Artificial Intelligence (LLMs) Lead the deployment of Large Language Models (LLMs) and Generative AI to automate protocol design, extract insights from unstructured clinical notes, and streamline regulatory documentation drafting. Oversee the implementation of Retrieval-Augmented Generation (RAG) architectures to securely query internal knowledge bases and scientific literature without hallucination risks. Develop "Agentic AI" workflows to enhance patient engagement and automate routine clinical operations tasks, while maintaining "human-in-the-loop" oversight for safety. Digital Biomarkers & Product Innovation Direct the R&D of novel digital biomarkers derived from wearable sensor data (ECG, PPG, accelerometry), utilizing advanced signal processing and deep learning techniques. Partner with the Chief Medical Officer to design validation studies that demonstrate the clinical utility of digital endpoints for use in regulatory decision-making. Drive the "Cardiac Intelligence" agenda by integrating multimodal data (genomic, phenotypic, and sensor-based) to refine patient stratification for precision cardiology. Clinical Trials & Real-World Evidence (RWE) Leverage Electronic Medical Records (EMR) and Claims data to construct synthetic control arms, optimize patient recruitment, and conduct long-term post-market surveillance. Implement predictive analytics for clinical operations, optimizing site selection and forecasting enrollment to minimize trial delays and costs. Manage the ingestion and harmonization of diverse Real-World Data (RWD) sources into a unified Common Data Model (CDM) to support cross-functional analysis. Team Leadership & Collaboration Recruit, retain, and develop a best-in-class team of data scientists, ML engineers, and biostatisticians, fostering an environment of innovation and scientific rigor. Collaborate closely with the CIO to ensure data infrastructure (cloud compute, storage) meets the demanding requirements of AI training and high-frequency sensor data analysis. Partner with the VP of Supply Chain to leverage data for inventory optimization and logistics forecasting.

Requirements

• Ph.D. or Master’s degree in Data Science, Bioinformatics, Computer Science, Statistics, or a related quantitative field.
• 15+ years of progressive leadership experience in data science or analytics, with at least 5 years in the life sciences, biotech, or pharmaceutical industry.
• Proven track record of deploying Large Language Models (LLMs) and Generative AI solutions in a regulated enterprise environment (experience with RAG and prompt engineering preferred).
• Deep expertise in developing and validating digital biomarkers or clinical endpoints using sensor data and time-series analysis.
• Strong working knowledge of Real-World Data ecosystems (EMR, Claims, Registry data) and experience with clinical data standards (CDISC, OMOP, FHIR).
• Demonstrated experience in clinical trial operations, including protocol optimization and patient recruitment strategies.
• Experience in Regulatory and Quality Management Systems including documenting and managing design history files and supporting and building regulatory submissions
• Executive presence with the ability to translate complex technical concepts into strategic business value for the Prolaio Leadership Team, Kardigan Executive Committee and Board of Directors.
• Comprehensive understanding of data privacy and regulatory compliance (GDPR, CCPA, HIPAA, FDA Software as a Medical Device guidelines).

Responsibilities

• Define and execute the enterprise data strategy, treating data as a product that drives value for Prolaio’s remote monitoring platform and Kardigan’s therapeutic development.
• Establish a robust data governance framework to ensure data quality, integrity, and traceability across the entire lifecycle, ensuring readiness for FDA regulatory submissions (21 CFR Part 11).
• Champion a "data-first" culture by promoting data literacy across clinical, operational, and commercial teams, aligning technical roadmaps with business objectives.
• Lead the deployment of Large Language Models (LLMs) and Generative AI to automate protocol design, extract insights from unstructured clinical notes, and streamline regulatory documentation drafting.
• Oversee the implementation of Retrieval-Augmented Generation (RAG) architectures to securely query internal knowledge bases and scientific literature without hallucination risks.
• Develop "Agentic AI" workflows to enhance patient engagement and automate routine clinical operations tasks, while maintaining "human-in-the-loop" oversight for safety.
• Direct the R&D of novel digital biomarkers derived from wearable sensor data (ECG, PPG, accelerometry), utilizing advanced signal processing and deep learning techniques.
• Partner with the Chief Medical Officer to design validation studies that demonstrate the clinical utility of digital endpoints for use in regulatory decision-making.
• Drive the "Cardiac Intelligence" agenda by integrating multimodal data (genomic, phenotypic, and sensor-based) to refine patient stratification for precision cardiology.
• Leverage Electronic Medical Records (EMR) and Claims data to construct synthetic control arms, optimize patient recruitment, and conduct long-term post-market surveillance.
• Implement predictive analytics for clinical operations, optimizing site selection and forecasting enrollment to minimize trial delays and costs.
• Manage the ingestion and harmonization of diverse Real-World Data (RWD) sources into a unified Common Data Model (CDM) to support cross-functional analysis.
• Recruit, retain, and develop a best-in-class team of data scientists, ML engineers, and biostatisticians, fostering an environment of innovation and scientific rigor.
• Collaborate closely with the CIO to ensure data infrastructure (cloud compute, storage) meets the demanding requirements of AI training and high-frequency sensor data analysis.
• Partner with the VP of Supply Chain to leverage data for inventory optimization and logistics forecasting.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Executive
• Education Level: Ph.D. or professional degree
• Number of Employees: 11-50 employees