Senior Clinical Operations Manager

About Kintsugi

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 and Fierce 15 in 2023, 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.

About the Team

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. 

The Role

As Kintsugi's Senior Clinical Operations Manager, 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 Director of Quality and Regulatory you will be designing and operationalizing clinical studies to validate Kintsugi’s voice biomarker software. You'll have the opportunity to oversee the clinical operational activities of study design, budget planning, defining project delivery timelines, developing and maintaining essential operational documentation, as well as managing data management and recruitment strategies as needed. 

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 $100k - $160k + Equity. Actual compensation may vary from posted base salary depending on your confirmed job-related skills and experience.

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

Responsibilities

• 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 

 

Qualifications

• 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).

 

Benefits:

 

• Competitive Salary
• 100% Remote Work (with Optional Onsite In San Francisco, CA)
• Unlimited 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 Of