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Senior Manager / Director
Kintsugi
posted 7hr ago
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Key skills for the job
Job Description
- 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.
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- 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.
Qualifications
- 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.
- Bachelors 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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Employment Type: Full Time, Permanent
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