Senior Manager - Director, Clinical Strategy and Operations

2 days ago

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Kintsugi

WebsiteLinkedInAll Job Openings

11 - 50 employees

🤖 Artificial Intelligence

⚕️ Healthcare Insurance

👥 HR Tech

Description

• 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, Kintsugi aims to close mental health care gaps. • As Senior Manager / Director, you will lead end-to-end clinical studies and contribute to clinical evidence strategy. • Oversee clinical operational activities, manage contractors, and drive regulatory submissions for voice biomarker software. • A unique opportunity to be a key player in AI device FDA approval.

Requirements

• 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.

Benefits

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