# Director of Clinical Affairs

Hiring organization: [Eight Sleep](https://career.thegoodapps.co/organizations/eight-sleep)

Canonical page: https://career.thegoodapps.co/jobs/5d0c21c3-847e-4aca-b1f7-aac8324626a7

Listed on Eight Sleep's own careers site. Applications go to them directly.

- Employment type: full time
- Seniority: Director
- Location: San Francisco, CA
- Remote: yes
- Salary: 200000 – 250000 USD per year

## Summary

This role leads the end-to-end design and execution of clinical studies for a medical device company, managing regulatory submissions, site coordination, and data operations. It suits someone with 10+ years of clinical ops experience who has successfully shepherded trials through FDA clearance and enjoys hands-on problem-solving in a fast-paced startup environment.

_Our summary, not Eight Sleep's wording._

## Skills named

Data Management

## Required

- 10+ years of clinical operations for FDA-regulated medical devices or SaMD
- 5+ years in leadership roles executing clinical studies
- Experience managing third-party clinical sites
- Track record of authoring IRB submissions and informed consent forms
- 7+ years of cross-functional program management with clinical, engineering, and regulatory teams
- Strong knowledge of clinical data management and eCRF design
- Working fluency in FDA device regulations (IDE, De Novo, 510k), ICH-GCP, and ISO 14155
- Experience with study budgeting, vendor management, and CRO oversight
- Demonstrated participation in trials leading to FDA clearances or labeling expansions
- Bachelor's degree

## Nice to have

- Advanced degree (MS, MPH, PhD, or clinical doctorate)
- ACRP or SOCRA certification
- Experience with biosensing or consumer health devices
- Familiarity with real-world evidence study designs or decentralized trials
- Prior work in high-growth startup or scale-up environments
- Experience supporting FDA breakthrough designations or pre-submission meetings

Apply on Eight Sleep's site: https://jobs.ashbyhq.com/eightsleep/3a7a9940-8137-4f9d-becd-e981de527218/application