Director of Clinical Research
New
T
Tiny HealthBiotech Diagnostics
United States, Canada, 9 am - 6 pm CSTFull-TimeDirector
Salary not disclosed
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Job Details
- Experience
- 6+ years
- Required Skills
- Data AnalysisCross-functional Team Leadership
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 such as CROs and academic collaborators.
- Experience operating in ambiguity and building scalable systems in early-stage or resource-constrained environments.
- Strong written and verbal communication skills.
- Experience supporting regulatory submissions is preferred.
- Background in pediatric, maternal-infant, or microbiome-related research is preferred.
- Experience generating evidence to support product claims is preferred.
- Track record of publications in peer-reviewed journals is preferred.
Responsibilities
- Co-own the 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.
- 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.
- Partner with Bioinformatics and Engineering to ensure analytical rigor and data capture.
- Collaborate with Product and Marketing to translate findings into defensible claims.
- Lead study reporting, including abstracts and peer-reviewed manuscripts.
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