As Kintsugi's Senior Manager / Director, Clinical Strategy and Operations, you will play a critical role in leading end-to-end studies of various scopes and sizes and contributing to our clinical evidence strategy and roadmap. Reporting to the Head of Strategy and Business Development, you will be driving strategic clinical product decisions, designing and operationalizing clinical studies to validate Kintsugi’s voice biomarker software, developing publications to support Kintsugi’s voice biomarker efficacy in a variety of clinical use cases, and leading FDA De Novo submissions and correspondence. You'll have the opportunity to oversee the clinical operational activities of designing studies, planning budgets, defining project delivery timelines, developing and maintaining essential operational documentation, hiring and managing contractors, as well as managing data management and recruitment strategies as needed. A unique opportunity, you will likely be one of half a dozen people in the U.S. who have taken an AI device through FDA De Novo approval.

Kintsugi offers a holistic Total Rewards package designed to support our employees in all aspects of their life inside and outside of work. The expected base salary for this position will range from $150k - $200k + Equity. Actual compensation may vary from posted base salary depending on your confirmed job-related skills and experience.

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Benefits:

• Competitive Salary
• 100% Remote Work
• Flexible PTO
• Comprehensive Health Benefits (80% coverage of Medical, Dental & Vision)
• 401(K)
• 12 months of company-paid therapy via Talkspace
• Monthly Wellness Stipend
• Education Stipend
• Office Setup Stipend
• Annual Off-sites
• 16 Paid Holidays
• Summer Fridays (Friday Afternoons Off)
• Paid Parental Leave

At the moment, we are unable to provide visa sponsorship for this role.

• Drive the sourcing, design, and execution of commercial and clinical studies to achieve desired outcomes, liaising with commercial and clinical collaborators to prioritize studies that meet the needs of the evidence strategy roadmap.
• 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.
  • Partner with statisticians and the machine learning team to develop hypotheses and ensure data completeness, quality, and integrity.
  • Lead the development of study reports for regulatory filings, white paper and/or peer review journal publication.
• Lead Kintsugi’s clinical FDA processes (QSubs, initial De Novo clearance, PCCP, subsequent 510k’s, etc.) in collaboration with Regulatory/QA, Product, Machine Learning, and Commercial teams.
• Support Quality and Regulatory processes and QMS development in compliance with FDA De Novo requirements for Software as a Medical Device (SaMD).
• Generate scientific manuscripts and abstracts for submission to reputable journals and clinical conferences.

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• 5+ years of commercial clinical operations and/or clinical strategy experience in health technology, diagnostics, or pharma. Clinical experience with an early stage health tech startup is highly preferred.
• Strong understanding and experience of FDA approval processes is a must.
• Understanding of regulatory processes and ability to collaborate with Regulatory/QA consultants and/or team members highly preferred.
• Proven ability to lead end-to-end studies of various scopes and sizes.
• Proficiency in study objectives, design, and statistical analysis plan.
• Demonstrated expertise in study operation and execution, including budget planning and project delivery timelines.
• Strong understanding and experience with protocol writing and development and IRB processes.
• Excellent written and verbal communication skills.
• Bachelor's degree in psychology, science, engineering, or related technical discipline.
• Ability to thrive in a fast paced, collaborative, resource constrained environment and wear multiple hats as needed.
• Strong skills in identifying investigators, collaborators, and other external clinical resources (e.g., recruitment agencies, CROs).
• Experience in developing and maintaining Manual of Operating Procedures (MOPs) and Standard Operating Procedures (SOPs).
• High attention to detail and a commitment to delivering quality outcomes.
• Startup mindset - ability to thrive in a fast-paced, dynamic environment:
  • Flexible, adaptable, and able to wear multiple hats and take on challenges outside of the defined role.
  • Agile and able to make decisions with imperfect information.
  • Willingness to take risks and learn from mistakes.

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Kintsugi is on a mission to scale access to mental healthcare for all. We are developing novel voice biomarker software to detect signs of depression and anxiety from short clips of free form speech. Awarded multiple distinctions for AI technology and recently named one of Forbes’ Top 50 AI companies to watch in 2022, Fierce 15 in 2023, and World Economic Forum Technology Pioneer in 2024, Kintsugi helps to close mental health care gaps across risk-bearing health systems, ultimately saving time and lives.

At Kintsugi, we believe that mental health is just as important as physical health. We exist to ensure that everyone who needs mental healthcare has access to the right care at the right time.

We're a female-founded organization, united and driven by our shared passion to revolutionize access to mental healthcare. Our mission is ambitious, and each member of our team wears multiple hats and plays a pivotal role. As an early-stage, Series A startup, we offer exciting growth opportunities and the chance to make a real impact. Join us to embark on a rewarding journey, learning and growing alongside our dedicated team of trailblazers.