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Open nowPosted 11 days ago

Senior / Principal Scientist, Preclinical and Clinical Research

Workable (global search)108,016 open roles

Where
Philadelphia, PA, United States
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Your applicationOpen nowSenior / Principal Scientist, Preclinical and Clinical ResearchWorkable (global search) · Philadelphia, PA, United States

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This job: posted 11 days ago

Workable (global search) median: 7 days open

The posting

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.

The Role

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.

What You'll Do

  1. 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.
  2. Manage all clinical and preclinical operations, including animal safety studies, protocol development, investigator relations, site coordination, patient recruitment, CRO management, monitoring, and study reporting.
  3. 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.
  4. Support regulatory submissions and FDA interactions.

Requirements

  1. Education: PhD work in human or NHP neuroscience or a closely related field.
  1. Clinical Trial / Human Subjects Experience: hands-on experience working with human subjects, ideally including patient populations.
  2. Technical fluency: programming and data-analysis skills (e.g., Python) sufficient to work with our data science team.

Preferred Qualifications

We don't expect any candidate to bring all of these — any two would make a strong application:

  1. Human or NHP intracranial recordings (iEEG, ECoG, sEEG, single/multi-unit)
  2. Direct electrical brain stimulation in humans
  3. Conduct of an IDE- or IRB-regulated clinical trial

Location

Based in Philadelphia alongside our data science team, with frequent travel to our Boston office and to study sites. We will also consider a Boston-based candidate who is prepared to spend significant time in Philadelphia.

Level and Compensation

Level (Senior Scientist vs. Principal Scientist) set by experience. Candidates with substantial industry clinical development leadership may be considered at the Associate Director level.

Benefits

  • Cash compensation
  • Stock options
  • Paid time off
  • Healthcare and dental benefits
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