Senior Clinical Operations Manager
Confirmed live in the last 24 hours

11-50 employees

Voice biomarker software for mental health detection
Company Overview
Kintsugi stands out as a leader in the mental healthcare industry, leveraging their unique voice biomarker software to detect signs of depression and anxiety, a technology that has earned them recognition from Forbes as one of the Top 50 AI companies to watch in 2022. Their strategic partnership with the Pega platform enables healthcare providers and payers to address mental health concerns in real-time during calls, potentially impacting millions of Americans. Kintsugi's commitment to bridging the gap in mental healthcare access, coupled with their advanced technology, positions them as a company that is not only addressing a critical societal issue but also shaping the future of mental healthcare.
AI & Machine Learning
Social Impact

Company Stage

Series A

Total Funding





Berkeley, California

Growth & Insights

6 month growth


1 year growth


2 year growth

Experience Level
Desired Skills
Operations & Logistics
  • 4-5 years of commercial clinical operations and/or clinical strategy experience in health technology, diagnostics, or pharma
  • Strong understanding and experience with protocol writing and development and IRB processes
  • Strong understanding and experience of FDA approval processes
  • Excellent written and verbal communication skills
  • Bachelor's degree in science, engineering, or related technical discipline
  • Ability to thrive in a fast paced, collaborative, resource constrained environment and wear multiple hats as needed
  • Proven ability to lead end-to-end studies of various scopes and sizes
  • Proficiency in study objectives, design, and statistical analysis plan
  • Strong skills in identifying investigators, collaborators, and other external clinical resources (e.g., CROs)
  • Demonstrated expertise in study operation and execution, including budget planning and project delivery timelines
  • Experience in developing and maintaining Manual of Operating Procedures (MOPs) and Standard Operating Procedures (SOPs)
  • Support the sourcing, design, and execution of commercial and clinical studies to achieve desired outcomes against prioritized endpoints
  • Own the end-to-end study operations process:
  • Develop study objectives and design
  • Identify appropriate resources and partners to support study execution and statistical analysis of the data
  • Shepard studies through IRB
  • Lead the development of study reports for regulatory filings, white paper and/or peer review journal publication
  • Collaborate with the Clinical and Regulatory/QA team on our FDA clearance process
  • Generate scientific manuscripts and abstracts for submission to reputable journals and clinical conferences
  • Liaise with commercial and clinical collaborators to design and stand up studies that meet the needs of the evidence strategy roadmap