Clinical Research Scientist at Imagen Technologies (Remote)
Imagen enables Primary Care providers to become technology-enabled multispecialty practices, powering a successful transition from fee-for-service to value-based care. Imagen’s comprehensive platform includes in-office diagnostic testing, diagnostic interpretations powered by proprietary FDA-cleared machine learning software, and virtual specialist consults. Imagen’s platform empowers Primary Care providers to achieve healthcare’s quadruple aim of increasing quality, lowering costs, and improving the patient and provider experience.
Imagen’s team includes over 100 clinical, technical, and business personnel. Imagen’s software has received first-of-its-kind FDA clearances, and its research has been published in leading peer-reviewed journals such as PNAS and Nature Digital Medicine. Imagen has raised $135 million in capital from investors such as Google Ventures, Casdin Capital, and Threshold Ventures. Imagen was founded in 2015 and is based in New York City.
We are looking for a Clinical Research Scientist to become an integral member of our rapidly expanding clinical research program. The clinical research team is responsible for testing the safety and efficacy of our AI technology with practicing clinicians and developing the strategies and submissions for regulatory clearance of our AI-enabled software as a medical device. We’re looking for a Clinical Research Scientist who can own clinical study design as well as draft regulatory submissions including Q-Submissions and 510(k) applications. Our ideal candidate maintains high standards, is intellectually curious, and has a strong sense of pragmatism required to operate effectively in a startup.
- Collaborate closely with machine learning scientists and product managers to design and execute study protocols for human subjects experiments
- Develop and propose regulatory strategies that incorporate high-level business goals
- Partner with internal stakeholders (e.g., product managers, scientists, and clinicians) and external stakeholders (e.g., consultants) to manage the delivery of high quality regulatory submissions
- Effectively communicate study results (verbally and written) to internal and external audiences (e.g., FDA, research publications)
- Oversee literature reviews, synthesize clinical information, and provide guidance and support to team members
- Ph.D. in an experimental science, such as biomedical sciences or experimental psychology
- Proven track record of designing experiments and weighing the strengths and weaknesses of alternative designs
- Experience with regulatory affairs and regulations for software as a medical device
- Excellent verbal and written communication skills
- Strong reasoning abilities and attention to detail
This role is remote or may be based in New York, NY
- 1-page cover letter
Imagen is committed to the principle of equal employment opportunity for all employees and applicants for employment and prohibits discrimination and harassment of any kind without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. Imagen will not tolerate discrimination or harassment based on any of these characteristics. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.