Elon Musk’s brain-machine interface company Neuralink has a new job posting for a clinical trial director, a position that could help the company move towards its stated goal of testing its brain implant in actual people.
Since launching publicly in 2017, Neuralink has demoed its brain implant in pigs and monkeys but has yet to announce a start to the long-promised trials in humans. The company’s implant is a coin-like device with electrodes studded on thin, flexible wires. The wires are its main innovation over older brain-machine interfaces, which use stiffer needles that can damage cells in the brain.
The company needs to do trials in humans before it can get Food and Drug Administration (FDA) approval for general medical use — key for Musk’s stated plan to use the devices to solve a number of neurological problems, from memory loss to addiction.
The clinical trial director job posting, first reported by Bloomberg, says that the person in the role will be “working with Neuralink’s first Clinical Trial participants,” though it’s not clear if the company has started recruiting or working with participants at this point. Musk said in December that the company aims to have the device implanted in the first human subjects in 2022. That’s not the first prediction he’s made, though — Musk previously said he hoped to start trials in 2020.
The clinical trial process would start with a feasibility study to get a first look at how the device works in a small number of people. Then, because the device is high-risk and hasn’t been previously used in people, the company would need FDA approval to launch a larger-scale trial. According to the job posting, the clinical trial director would be responsible for interactions with regulators like the FDA.
The person who takes the clinical trials director position will enter a scientific environment that ex-employees told Stat News in 2020 was chaotic and was characterized by pressure to deliver scientific progress on unreasonably short timelines. They’d have to handle Musk’s consistent promises of timelines that haven’t previously panned out and his publicly-stated ambitions that still go beyond what scientists say are reasonable expectations for brain-machine interfaces. None of that is in the job description.
Source: https://www.theverge.com/2022/1/20/22893444/neuralink-human-clinical-trials-musk