Clinical Research Director

Neurolab Inc.; Boston (MA); On-site; USD 180,000 - 280,000; Full time

Job summary

Neurolab Inc. is seeking a seasoned leader to drive our clinical research program from protocol design through patient enrollment and data analysis.

You will report to the CSO and ensure the integrity and pace of our clinical validation pipeline. The role requires MD or PhD and a track record of leading clinical studies for medical devices or neurotechnology, with experience in FDA IDE submissions and GCP compliance.

Qualifications

• MD or PhD in Clinical Neuroscience, Biomedical Engineering, or related field
• 10+ years in clinical research leadership for medical devices or neurotechnology
• Experience with FDA IDE submissions and GCP compliance
• Track record of successful clinical studies from design to publication

Responsibilities

• Design and execute Phase I/II clinical studies for neural interface devices
• Manage relationships with clinical trial sites, PIs, and CROs
• Oversee IRB submissions, informed consent, and regulatory documentation
• Build and lead a clinical research team of coordinators and data managers
• Present results to regulatory bodies, advisory boards, and investors

Job description

You will lead Neurolab's clinical research program from protocol design through patient enrollment and data analysis. This role reports directly to the CSO and is responsible for the integrity and pace of our clinical validation pipeline.

What You'll Do

• 01 Design and execute Phase I/II clinical studies for neural interface devices
• 02 Manage relationships with clinical trial sites, PIs, and CROs
• 03 Oversee IRB submissions, informed consent, and regulatory documentation
• 04 Build and lead a clinical research team of coordinators and data managers
• 05 Present results to regulatory bodies, advisory boards, and investors

What We're Looking For

• MD or PhD in Clinical Neuroscience, Biomedical Engineering, or related field
• 10+ years in clinical research leadership for medical devices or neurotechnology
• Experience with FDA IDE submissions and GCP compliance
• Track record of successful clinical studies from design to publication

Nice to Have

• Board certification in neurology or neurosurgery
• Prior experience with implantable device clinical programs (DBS, cochlear)

Department

Clinical Operations

Field Research · Patient Advocacy · Lab Management