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Director of Clinical Research

📅 Jul 7
Clinical Research StrategyClinical Study DesignHuman Clinical StudiesIRB Submissions
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📜 Description

  • Co-own the clinical evidence roadmap and define study objectives, endpoints, and success criteria.
  • Build scalable clinical research processes and infrastructure.
  • Design and lead observational, interventional, and real-world evidence studies; oversee protocols, analysis plans, and data collection.
  • Manage study timelines, budgets, risks, and regulatory documentation; support regulatory submissions.
  • Partner across Bioinformatics, Engineering, Product, and Marketing to ensure rigor and communicate defensible findings.
  • Lead study reports, abstracts, manuscripts, and presentations for internal and external audiences.

🛠️ Requirements

  • PhD, MD, MS/MPH, or equivalent degree in life sciences, clinical research, or a related field
  • 6+ years of experience in clinical research within biotech, diagnostics, digital health, or academia
  • Demonstrated experience designing and executing human clinical studies
  • Hands-on experience with IRB submissions and human subjects research oversight
  • Experience leading cross-functional teams and managing external partners (CROs, academic collaborators, etc.)
  • Strong written and verbal communication skills
  • Experience operating in ambiguity and building scalable systems in early-stage or resource-constrained environments
  • Experience supporting regulatory submissions
  • Background in pediatric, maternal-infant, or microbiome-related research
  • Experience generating evidence to support product claims or regulatory strategy
Full job description

About Tiny Health

Tiny Health is advancing lifelong health, from the first 1,000 days to the last, and addressing chronic disease through precision microbiome science. Founded in 2020 and built by microbiome scientists and physicians, our testing platform reveals whether your microbiome is trending toward resilience or imbalances using shotgun metagenomics, proprietary AI, and one of the world's largest longitudinal datasets. Trusted by families and health practitioners alike, our research-backed gut and vaginal tests are redefining the microbiome as a cornerstone of personalized health through every life stage. Learn more at tinyhealth.com and poweredbytiny.com.

The Opportunity

Tiny Health is seeking a Director of Clinical Research to co-own the strategy, execution, and growth of our clinical research program. This role will lead the design and delivery of clinical studies supporting product validation, regulatory strategy, and scientific credibility across our microbiome-based testing and health insights.

As a key scientific leader, you will help build and scale our clinical research infrastructure in a fast-moving, resource-conscious environment, balancing rigor with speed as the program grows.

What You’ll Do

Clinical Strategy & Infrastructure

  • Co-own Tiny Health’s clinical evidence roadmap with the Head of Science

  • Define study objectives, endpoints, and success criteria aligned with product and regulatory goals

  • Build scalable clinical research processes and infrastructure as the company grows

  • Represent Tiny Health in clinical collaborations and external research discussions

Study Design & Execution

  • Lead the design and publication of observational, interventional, and real-world evidence studies

  • Oversee protocol development, statistical analysis plans, and data collection frameworks

  • Manage study timelines, budgets, risk, and regulatory documentation

  • Support regulatory submissions as needed

Cross-Functional & Scientific Communication

  • Partner with Bioinformatics and Engineering to ensure analytical rigor and appropriate data capture

  • Collaborate with Product and Marketing to translate findings into clear, defensible claims

  • Lead study reporting, including reports, abstracts, and peer-reviewed manuscripts

  • Present findings to internal leadership, partners, and scientific audiences

Qualifications

Required

  • PhD, MD, MS/MPH, or equivalent degree in life sciences, clinical research, or a related field

  • 6+ years of experience in clinical research within biotech, diagnostics, digital health, or academia

  • Demonstrated experience designing and executing human clinical studies

  • Hands-on experience with IRB submissions and human subjects research oversight

  • Experience leading cross-functional teams and managing external partners (CROs, academic collaborators, etc.)

  • Strong written and verbal communication skills

  • Experience operating in ambiguity and building scalable systems in early-stage or resource-constrained environments

Preferred

  • Experience supporting regulatory submissions

  • Background in pediatric, maternal-infant, or microbiome-related research

  • Experience generating evidence to support product claims or regulatory strategy

  • Track record of publications in peer-reviewed journals

How we work

  • A mission that actually pulls people in
    We make the microbiome measurable and actionable at every life stage, and real people write in to say it's life-changing.

  • Remote-first, real overlap
    Our FTEs are based in North America and work core hours from 9am–6pm CST, shiftable by up to two hours either way — start at 7am or 11am, wrap at 4pm or 8pm.

  • Written first, huddle second, meet last
    Default to a clear Slack post, huddle when a thread stalls, and meet only to make a real decision.

  • Fast, but never sloppy
    Do the two-month thing in two weeks, then check the work—shipping errors is rework, not speed.

  • Shape what we build, not just how we build it
    There's no playbook waiting for you, so write it—and bring the alternative, not just the objection.

  • Day One mentality
    Fewer titles and layers; process is a guardrail where it counts, never the reason something didn't ship.

  • No hidden agendas
    Numbers, misses, and feedback are shared openly and in real time, so you always know where you stand.

  • High standards, genuinely fun people
    Take the work seriously and ourselves much less—high-performing and fun to be around is the hiring bar.

  • Is this pace for you?
    Venture-scaled and on a steep trajectory, with intensity in spikes, fiercely protected flexibility, and faster growth than anywhere else.

Our Values

  1. Learn Fast, Get Better - Find the root cause, not just the fix, and get better every time

  2. Be Relentlessly Resourceful - Dig for the answer, move fast, and know when to ask for help

  3. Act Like an Owner, Be Hungry to Win - Act like it’s your company, and do whatever it takes to win

  4. Act with Honesty and Empathy - Say what’s true, and say it with care

  5. Delight People by Anticipating Their Needs - Solve the problem, then get two steps ahead of it

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