Senior / Principal Scientist, Preclinical and Clinical Research
About The Position
Nia Therapeutics has received FDA breakthrough device designation for its Smart Neurostimulation System — A wireless, 60-channel, AI-enabled neurostimulation platform. We aim to evaluate the safety and efficacy of this system for the treatment of memory loss in patients with acquired brain injury and neurodegenerative disease. This therapy could provide hope for the more than 27 million Americans living with debilitating memory loss. Working closely with the CEO, Dr. Michael Kahana, and our data science team, you will develop and execute the clinical plan for our Early Feasibility Study (EFS), complete the clinical protocol for our IDE application, participate in FDA program meetings, and help lay the groundwork for subsequent pivotal trials. In preparation for the EFS, you will manage our ongoing pre-clinical animal safety trials. You will also contribute to grant applications in support of our clinical studies and assemble the team that will carry out our planned clinical trials. This role requires regular presence in the clinic, responsibility over data integrity, and direct involvement in data analysis.
Requirements
- PhD work in human or NHP neuroscience or a closely related field.
- Hands-on experience working with human subjects, ideally including patient populations.
- Programming and data-analysis skills (e.g., Python) sufficient to work with our data science team.
Nice To Haves
- Human or NHP intracranial recordings (iEEG, ECoG, sEEG, single/multi-unit)
- Direct electrical brain stimulation in humans
- Conduct of an IDE- or IRB-regulated clinical trial
Responsibilities
- Contribute scientifically to study design and the development of memory and cognitive outcome measures, to data analysis, publications and presentations, and to federal grant applications.
- Manage all clinical and preclinical operations, including animal safety studies, protocol development, investigator relations, site coordination, patient recruitment, CRO management, monitoring, and study reporting.
- Build and maintain the EDC systems, data management plans, and trial datasets in compliance with GCP, 21 CFR Part 812, and ISO 14155, with the data science team.
- Support regulatory submissions and FDA interactions.
Benefits
- Stock options
- Paid time off
- Healthcare and dental benefits
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Ph.D. or professional degree
