Boston, MA /
Health & Medical /
At WHOOP, we're on a mission to unlock human performance. WHOOP empowers its members to perform at a higher level through a deeper understanding of their bodies and daily lives.
WHOOP is developing machine learning algorithms and other digital endpoints that span health and wellness, pushing the limits of what wearables can do. As Clinical Director, you will oversee our medical device programs to bring new health features to market. You will own the end to end process of bringing a new SaMD to market from developing the clinical regulatory strategy, to partnering with internal and external stakeholders to the design and execution of clinical trials, to bringing these products through regulatory filings.
- Collaborate with internal stakeholders across Data Science, Hardware, Legal, Regulatory, Quality, Product, and Enterprise to develop and execute WHOOP’s medical device strategy.
- Develop clinical strategies to efficiently generate evidence supporting an evolving set of product claims.
- Own the medical device process from study design and protocol development for digital endpoints and outcomes through final study report and regulatory filings.
- Ensure trials are executed in accordance with FDA regulations, IRB approval, and follow clinical best practices.
- Work with executives and legal to establish company policies and SOPs for clinical affairs.
- Oversee Investigator selection, recruitment, and training as well as interact with investigators and study sites during study.
- Contribute to Informed Consent Documents, Investigator Brochures, and IRB/Ethics Committee and regulatory agency submissions as needed
- Review and evaluate clinical study data.
- Provide presentations of clinical study information to management as needed.
- Collaborate with Marketing to develop go to market strategies, claims substantiation plans, and ensure the medical device is being correctly represented.
- Reports to the Chief Medical Officer.
- MD, PhD or PharmD with four or more years of clinical research experience; preference for clinical experience in cardiometabolic health.
- Experience in designing, monitoring and implementing clinical trials and interpreting trial results.
- Experience obtaining FDA clearance or approval for medical devices, preferably including medical devices with a software component (CE mark experience is a plus).
- Familiarity with early phase development and regulatory filings.
- Experience with the use of wearable sensors, digital health, mobile health, analytics, or other technology applications in a clinical setting.
- Familiarity with evolving regulatory guidance around new digital medical technologies.
- Business understanding of the digital health market and the broader technology industry, including wearable sensors, machine learning, and other developments.
- Familiarity with emerging healthcare trends, including value-based payment, real-world evidence, consumerization, and virtual care.
- Experience with HEOR is a plus.
- Publication track record.
- Experience with presenting and communicating to a broad array of audiences.
WHOOP is an Equal Opportunity Employer and participates in E-verify to determine employment eligibility.