Team Description:

The Preclinical team is responsible for the design, conduct, documentation, analysis, and reporting of preclinical studies. It is our responsibility to provide a means for ensuring the implantation of Neuralink devices into animals, and ultimately humans is safe, effective, and robust.

Job Description and Responsibilities:

The Study Manager will interact with Neuralink’s technical and clinical teams, as well as senior staff, to ensure that preclinical bench, pilot, R&D, and safety studies are carried out, critical data is gathered to support regulatory filings, and methods comply with good laboratory practices (GLP), if applicable. You will work closely with a Study Director to compile data, handle reporting, communicate cross-functionally, establish timelines, and eliminate roadblocks that halt progress. The Study Manager is the main point of contact for assigned studies.

• Designing studies
• Writing Protocols
• Interacting directly with the Sponsor, SD, and other teams to get the important information needed for a study, including:
• Communicating and ensuring timelines are followed
• SOPs are in place and followed
• Staff training to be completed
• Following up with key players throughout the study duration and leading key meetings
• Reviewing reports cross-functionally
• Helping write reports, when appropriate
• Generating deviation reports in response to QA audits
• Internally improving our information process, execution, and finalization of details and documents, generating tracked documents on our internal laboratory management system
• Representing our team across company communication channels

Key Qualifications:

• Evidence of exceptional technical depth in neuroscience, biomedical engineering, or a related field.
• 3+ years of academic or industry experience managing research projects.
• Experience working with, or a working knowledge of, medical devices.
• A strong understanding of the scientific method and engineering first principles.
• Demonstrated ability to effectively manage a project, lab, or study.
• Exceptional technical writing and data analysis abilities.
• Natural capacity to communicate cross-functionally between teams and departments.
• Organized and independent worker.
• Can deliver high-quality results rapidly and consistently without sacrificing quality.
• Basic computer skills. Proficient in Google Docs and Sheets, Google Drive, and Gmail.

Preferred Qualifications:

• Experience with, or, an understanding of, GLP and FDA guidelines.
• Experience working alongside technical and operational teams.
• Coding (SAS, R, Matlab, Python, SQL) and automated process development.

Physical Requirements: Ability to travel to/from work in Fremont and Austin.

Work Environment: Office, but could include vivarium, laboratory, and operating room.