Related skills
r sql wearables samd endpoints📋 Description
- Own clinical evidence strategy for SaMD across product lifecycle.
- Translate concepts into indications, endpoints, and evidence plans.
- Define validation study design, endpoints, and analysis criteria.
- Lead feasibility, validation, and post-market studies for regulatory goals.
- Guide FDA/CE submissions and regulatory content development.
- Build and mentor a scalable Clinical Science organization.
🎯 Requirements
- Advanced degree (PhD/MD/PharmD/DrPH/MPH/MS) or equivalent.
- 10+ years in clinical science or regulated healthcare.
- 5+ years leading clinical science teams.
- Experience in evidence generation for regulated products (SaMD/digital health).
- Expertise in study design, endpoints, validation, and analysis planning.
- Experience with FDA/CE submissions and regulatory interactions.
🎁 Benefits
- Competitive compensation, meaningful equity, and comprehensive benefits.
- Equity package aligns long-term success with ownership.
- Shape clinical science at a fast-growing health tech company.
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