Director, Clinical Operations

Whoop Whoop · Consumer · Boston, MA · Health & Medical

Lead clinical operations for regulated and unregulated health features, focusing on SaMD, from concept to post-market evidence generation. Requires expertise in clinical trial operations, decentralized trials, vendor oversight, and execution in regulated healthcare environments. Will build and mentor a Clinical Operations organization.

What you'd actually do

  1. lead the clinical operations function responsible for executing the studies that support WHOOP’s regulated and unregulated health features, with a particular focus on Software as a Medical Device (SaMD)
  2. own operational strategy and study execution across the product lifecycle, from early concept and feasibility through validation, regulatory submission, launch, and post-market evidence generation
  3. oversee studies conducted through CROs as well as internally executed studies, ensuring high-quality, efficient, and compliant execution across WHOOP’s clinical portfolio
  4. build and mentor a high-performing Clinical Operations organization
  5. strengthen WHOOP’s clinical operations capabilities and ensure our study execution strategy meets the expectations of regulators, investigators, participants, and the business

Skills

Required

  • clinical trial operations
  • decentralized clinical trials
  • vendor oversight
  • regulated healthcare environments
  • SaMD

Nice to have

  • leadership
  • mentoring

What the JD emphasized

  • deep expertise in clinical trial operations
  • decentralized clinical trials
  • vendor oversight
  • operational execution within regulated healthcare environments
  • high-quality, efficient, and compliant execution