Head of Clinical and Regulatory Affairs

Motif is a medical device startup based in Houston, Texas. We are designing and developing minimally invasive electronic solutions for serious mental health conditions. Powered by our patent-pending methods for wireless power and data transmission, our goal is to create the smallest implantable brain stimulator to treat people with mental health disorders.

We are an early-stage startup with funding from venture capital firms, grants, and private angel and founder investments.

Motif’s technology stack consists of a small implant that is wirelessly powered via magnetic fields from an external wearable transmitter, configured and controlled from a programming interface. It delivers novel stimulation therapy to cortical targets and will evolve to record biomarkers of symptoms, disease state, and therapy response.

We are currently completing the development of our first minimally invasive neural stimulation system and preparing for future versions with additional functionality based on our platform technology.

We are seeking candidates with experience leading multi-site clinical trials for implantable neuromodulation devices to join our team as Head of Clinical and Regulatory Affairs
.

This role is responsible for overseeing Motif’s clinical department and functions including Clinical Affairs, Clinical Operations, Clinical Science, and Regulatory Affairs. Within Clinical Operations specifically, you will be responsible for running our clinical trials from end-to-end. You will partner closely with Leadership, Quality, R&D, Operations, and Marketing teams, in service of a technology with the potential to change how mental health is treated.

Job Location:

Remote (Houston, Texas preferred)

• You’ve run a multi-site clinical trial for an implantable neuromodulation device and know exactly what can go wrong… and how to avoid it!
• You enjoy cross-functional coordination to stitch together clinical evidence generation, clinical execution, and regulatory necessities.
• You want to build a scalable clinical function that plans and manages its own work, rather than one that depends on you for every decision.
• You thrive with direct strategic communication with leadership helping to ensure all the pieces work together.
• You are excited by the opportunity to represent Motif at industry podiums and with KOLs, but you’re just as comfortable personally chasing down a site activation delay.

If yes to the above, then you may love working with Motif as it is being built by highly dedicated people with passion for neurotechnology, clinical product development, and putting the patient first. We are looking for people with the same energy who will thrive in a high growth, high autonomy environment.

• Oversee all clinical functions and own the clinical lifecycle end-to-end, with an immediate focus on Clinical Operations - ensuring sites are activated, patients enrolled, contracts signed, and Field Clinical Engineers executing studies as planned.
• Oversee and lead execution of multi-national industry-sponsored clinical trials in partnership with CROs, specialized vendors, and consultants.
• Oversee study design, site strategy, patient recruitment, and data quality to meet regulatory and product performance goals.
• Oversee endpoint selection, statistical analysis plans, and data interpretation.
• Oversee development and execution of an evidence strategy spanning sponsored, partnered, and grant funded science that informs future studies, supports technical derisking, and that generates confidence for future investors
• Manage trial timelines, budgets, and operational risk, with proactive mitigation plans.
• Ensure studies are delivered…