Nia Therapeutics has received FDA Breakthrough Device designation for its Smart Neurostimulation System, a wireless, 60-channel, AI-enabled neurostimulation platform. The company aims to evaluate the safety and efficacy of the system for treating memory loss in patients with acquired brain injury and neurodegenerative disease.

About the role

Working closely with CEO Dr Michael Kahana and the data science team, this role develops and executes the clinical plan for the Early Feasibility Study, completes the clinical protocol for the IDE application, participates in FDA program meetings, and lays the groundwork for subsequent pivotal trials. In preparation for the EFS, it also manages the ongoing preclinical animal safety trials.

The role requires regular presence in the clinic, responsibility over data integrity, and direct involvement in data analysis.

What you will do

• Contribute scientifically to study design, the development of memory and cognitive outcome measures, data analysis, publications and 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 EDC systems, data management plans and trial datasets in compliance with GCP, 21 CFR Part 812 and ISO 14155.
• Support regulatory submissions and FDA interactions.

What they are looking for

• PhD work in human or non-human primate neuroscience or a closely related field.
• Hands-on experience working with human subjects, ideally including patient populations.
• Programming and data analysis skills, such as Python, sufficient to work with the data science team.
• Preferred, with any two making a strong application: human or NHP intracranial recordings, direct electrical brain stimulation in humans, or conduct of an IDE or IRB-regulated clinical trial.

The role is based in Philadelphia alongside the data science team, with frequent travel to the Boston office and study sites. Level is set by experience, and candidates with substantial industry clinical development leadership may be considered at Associate Director level.