Senior Clinical Operations Manager at Kintsugi

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Remote

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 Off)
Paid Parental Leave

WARNING.

We have recently been made aware of online solicitations falsely using the Kintsugi name and trademarks that are pretending to hire potential applicants. This includes fake job descriptions and impersonation of our Recruitment team's profiles.

Please only respond to messages received from the kintsugihealth.com domain. All legitimate career opportunities are posted on this page. If you’d like to flag any suspicious activity, please forward it to support@kintsugihealth.com.

Further, if you have provided personally identifiable information (such as social security number, bank numbers or credit card information) to an unauthorized party, please contact one of the following agencies to report this disclosure and receive guidance on any further actions you should take to protect your identity:

FTC toll free hotline: 877-FTC-HELP (877-382-4357)
FTC online complaint form (http://www.ftc.gov/)
Internet Fraud Complaint Center (http://www.ic3.gov/)
Non-emergency number for your local police department.

Kintsugi on Diversity

Kintsugi Mindful Wellness, Inc. is an equal opportunity employer, and we value diversity in all its forms. We do not discriminate on the basis of race, religion, color, national origin, gender identity, sex, sexual orientation, gender identity, age, marital status, genetic information, veteran or disability status.

We are committed to recruit, hire, and develop an exceptional team of individuals aligned by a common vision of the future of computing. We recognize that our team is strongest when we respect and embrace differences while cultivating a culture of inclusion across race, gender, age, religion, identity, orientation, beliefs, and life experiences that make us unique. Our diversity is what drives our greatest achievements.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

E-Verify Federal Program

Kintsugi is participating in the federal government’s E-Verify program, which confirms employment authorization of all newly hired employees and most existing employees through an electronic database maintained by the Social Security Administration and Department of Homeland Security. For new hires, the E-Verify process is completed in conjunction with the Form I-9 Employment Eligibility Verification on the first day of work. E-Verify is not used as a tool to pre-screen candidates. For up-to-date information on E-Verify, go to www.uscis.gov and click on 'E-Verify' located near the bottom of the page.

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