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Regulatory Clinical Scientist at Aidoc. Location Information: USA. Description. None . About Aidoc. Aidoc helps health systems deliver smarter and faster care when it matters most. Its mission is to transform patient outcomes through ‘always on’ clinical AI, eliminating preventable care gaps that lead to loss of lives and disabilities. Through our proprietary aiOS™ platform, Aidoc seamlessly integrates real-time intelligence into provider workflows, helping physicians make faster clinical decisions for over 45 million patients a year. With the most FDA-cleared AI solutions in its category and deployments across 150+ health systems globally, Aidoc elevates the physician and patient experience.. Backed by General Catalyst, Square Peg, NVentures (NVIDIA’s venture arm), and four major U.S. health systems, Aidoc has raised $370 million to date, including a recent $150 million round to accelerate development of CARE™, its clinical-grade foundation model.. About this role. This position focuses on shaping and advancing pivotal study design strategy for AI-enabled medical devices.You will be responsible for designing and authoring pivotal study protocols, as well as planning, writing, and executing pivotal study reports that demonstrate clinical value and align with regulatory requirements. This role requires both creative and critical thinking, balancing established, well-tested study methodologies with innovative approaches enabled by large-scale real-world data and Aidoc’s solution deployments. You will collaborate closely with product, regulatory, clinical, and AI teams to establish new paradigms for clinical evidence generation in a rapidly evolving field.. This position is located in the US (remote).. Responsibilities. Lead the design of pivotal clinical studies, incorporating both traditional and novel approaches to study design.. Write, edit, and manage pivotal study protocols, statistical analysis plans, and study reports.. Partner with product, regulatory, and AI teams to align study design with product strategy and regulatory requirements.. Develop innovative real-world study designs that leverage large-scale Aidoc implementations.. Perform and interpret statistical analyses to inform study design and study outcomes.. Contribute to the preparation of regulatory submissions, including pivotal study documentation.. Stay abreast of evolving clinical research methodologies and regulatory guidance, particularly in AI-enabled medical devices.. Requirements. Advanced degree (Masters or PhD) in Biostatistics, Epidemiology, Clinical Sciences, or related field.. 3+ years experience navigating AI study designs and regulatory expectations for AI-driven devices.. Demonstrated expertise in clinical research design and statistical analysis.. Proven ability to write and manage clinical study protocols and study reports.. Strong critical thinking and analytical skills with a track record of creative, outside-the-box study design approaches.. Excellent written and verbal communication skills, with experience in scientific publications or regulatory submissions.. Strong drive to innovate and create new paradigms for clinical evidence generation in emerging device categories.. Working at Aidoc. We’re a dynamic, collaborative and fast growing team of more than 400 global employees, committed to improving the world of healthcare. We’re looking for mission-driven people excited to do transformative work.. We have offices in Tel Aviv and New York City, but Aidoc is a remote-first workplace. We’re able to hire US-based employees across the continental United States, although certain roles may be region-specific.. What we offer:. A range of medical, dental and vision benefits. Stock options for all full-time employees. 20 days of paid vacation, plus sick days and holidays. A 401(k) plan, life insurance, plus long and short term disability. The opportunity to directly improve medical care and impact patient outcomes. Aidoc is deeply committed to creating an inclusive and diverse workplace, and to the principle of equal opportunity for all individuals. We prohibit harassment of any type as well as discrimination based on race, color, religion, sex, sexual orientation, national origin, age, disability, veteran status, or any other status protected by law.