Neuralink Seeks Clinical Trial Director as Testing of Brain Chip in Humans Progresses

Photo: Woke Studio

After successful trials on a pig and a monkey, Neuralink is moving to a new stage of development in order to alleviate human suffering as soon as possible. The company is looking for a Clinical Trial Director as clinical trials of the brain chip in humans are approaching.

Elon Musk founded Neuralink with the goal of solving a wide range of brain-related problems with a Brain Machine Interface (BMI) device dubbed “Link.” A coin-sized chip could be implanted in the brain, where thin electrodes stimulate neurons. The main task of Neuralink is to empower people, primarily those who suffer from neurological diseases, to live life to the fullest. For example, paralyzed people with severe spinal cord injuries may be able to control electronic devices with their minds. In addition, it is possible to partially or completely restore the functionality of the entire body.

Musk said that he is “cautiously optimistic” that Neuralink will be able to “restore full-body functionality” to paralyzed individuals, and even give people the ability to “be able to walk again, naturally.” “It’s a super big deal, I don’t want to raise hopes unreasonably but I am increasingly convinced that this could be done,” Musk said.

The company has already conducted a series of animal tests that have been successful. In August 2020, the company demonstrated how the brain chip works in pigs. In April 2021, Neuralink demonstrated the work of the chip implanted in a monkey. The company is now gearing up for human trials, as co-founder Elon Musk announced in December 2021.

Since the first human trials were planned as early as this year, Neuralink is actively preparing for this. The company took a big step and began searching for a Clinical Trial Director.

“As the Clinical Trial Director, you’ll work closely with some of the most innovative doctors and top engineers, as well as working with Neuralink’s first Clinical Trial participants! You will lead and help build the team responsible for enabling Neuralink’s clinical research activities and developing the regulatory interactions that come with a fast-paced and ever-evolving environment. You are mission-driven and are able to meet tight deadlines with accuracy and efficiency.”

The company also posted examples of concrete duties:

• Support Neuralink clinical studies, including selection of CRO, site qualification and initiation, training, monitoring, close-out activities, device accountability, etc. as well as ensuring compliance with regulations and standards for clinical research
• Interact directly with regulatory agencies and the site-responsible clinical trial investigator
• Ensure timely and thorough monitoring visits to review and assure the rights, welfare, and safety of study participants are protected, and ensure integrity of clinical data with respect to accuracy, accountability, documentation, and adherence to procedures through review of eCRFs, source documents, medical records, and regulatory documents.
• Support site initiation activities, audits and site audit preparation in anticipation of site inspections.
• Develop and author regulatory submissions and provide critical input on cross-functional project teams
• Develop and implement SOPs for clinical research/trials and related activities
• Maintain a working knowledge of and assure compliance with Good Clinical Practices, Federal Regulatory requirements, Risk-Based Approach to Monitoring, and Neuralink SOPs
• Review Change Orders and assess regulatory impact of product changes on regulatory strategy and submissions per standard procedures
• Assist Community Engagement team with recruitment of study participants

Neuralink is betting that expanding the capabilities of the human brain will allow people not only to cope with serious diseases, but also to compete with artificial intelligence, which Musk believes is a threat to humanity.

© 2022, Eva Fox | Tesmanian. All rights reserved.

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