Clinical Research Scientist

WHO WE ARE

At Presage Technologies, we believe in improving the quality of healthcare while also making it more affordable and accessible. Over 90% of the world’s population haves access to a device that can power our software, but less than half have access to basic health services. We are aiming to close that gap by developing cutting-edge artificial intelligence and video analytics to transform consumer electronics and mobile phone consumer apps into sophisticated health sensing platforms.

WHAT YOU’LL DO

We are seeking a Clinical Research Scientist to drive the development, justification, and execution of the clinical evidence that underpins our regulatory submissions. You’ll have end-to-end ownership of study design, statistical rationale, presubmission documentation, and collaboration with clinical partners to ensure our evidence generation is rigorous, efficient, and aligned with FDA expectations.

KEY RESPONSIBILITIES:

• Design and justify clinical studies for regulatory submissions, including sampling frameworks, statistical power analyses, endpoints, reference methods, and population considerations.
• Author presubmission and scientific documentation, translating complex clinical, statistical, and technical concepts into clear, audit-ready materials for FDA and partner institutions.
• Develop and standardize study protocols, statistical analysis plans, and documentation templates to ensure consistency, traceability, integrity of data, and regulatory alignment across all evidence-generation activities.
• Lead collaboration with clinical partners and research sites, coordinating IRB submissions, site preparation, and execution of clinical and bench testing.
• Oversee on-site or remote study activities, including device setup, data collection workflows, operational troubleshooting, and adherence to protocol requirements.
• Interpret early data outputs from sensors, algorithms, and clinical studies to assess signal quality, data sufficiency, and alignment with intended use claims.
• Develop and communicate the scientific rationale behind study designs to internal teams, physicians, and external stakeholders, ensuring shared understanding of clinical and statistical foundations.
• Support human factors and usability assessments, contributing to study design, execution, and documentation of user interaction patterns and risks.
• Collaborate with engineering, scientific, and regulatory teams to ensure that study designs reflect product capabilities and generate evidence needed for submissions.
• Contribute to evidence governance, including documentation structure, data traceability, and justification narratives needed for FDA review and audit readiness.
• Identify high-impact opportunities to accelerate clinical validation, reduce study costs, and refine evidence strategies as the technology and regulatory landscapes evolve.
• Maintain flexibility to support adjacent scientific, quality, or testing initiatives, based on organizational needs and evolving clinical programs.

This is a remote role. Preference will be given to candidates based in St. Louis, Missouri or willing to relocate to St. Louis, Missouri.

WHO YOU ARE

You are a curious, analytical, and highly capable scientist who loves solving complex clinical and statistical problems. You’re energized by building structure where it’s needed, communicating clearly across diverse teams, and contributing to a rapidly evolving product in a startup environment. Your skill set enables you to design rigorous studies, interpret data with confidence, and translate scientific work into clear, compelling documentation. You excel when you can bring together clinical, technical, and strategic thinking. To thrive here, you bring the following qualifications:

• Experience designing or contributing to clinical trials, clinical research protocols, or regulated study frameworks.
• Ability to perform statistical modeling and develop defensible sample-size and power calculations.
• Exceptional scientific and technical writing skills (e.g., clinical protocols, presubs, scientific papers, or technical reports).
• Experience collaborating with clinical partners, IRBs, or research institutions.
• Strong ability to interpret data from algorithms, sensors, or biomedical measurements.
• Experience with reviewing FDA regulations and developing proposals for clinical trials that fulfill FDA’s requirements for medical device clearance. Cognizance of tools and techniques for managing the economics of such trials is highly valued.
• Comfortable representing the company to physician groups, external partners, and research sites.
• Able to work across engineering, science, and regulatory teams with clarity and initiative.

Desirable:

• MS or PhD in biostatistics, biomedical engineering, clinical research, medical sciences, or a related quantitative field.
• Experience with FDA medical device submissions (Pre-Subs, IDE, 510(k), etc.).
• Prior authorship of scientific papers or structured technical reports.
• Familiarity with human factors/usability testing.
• Experience with SaMD, digital health validation, or physiological signal analysis.

If you’re excited by the opportunity to design meaningful clinical studies and contribute to breakthrough medical technologies, we’d love to talk.

INTERVIEW PROCESS

• Phase 1: Submit a Resume
• Phase 2: Downselection for Introductory Interview with Q&A
• Phase 3: Downselection for Technical Interview
• Negotiations and Offer
• Timeline: The entire process can occur in less than two weeks for the right candidate.

Salary Range

$150,000 - $190,000 (base) per year plus a 10% bonus