Head of Clinical and Regulatory Affairs

About the Job

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.

If you have a passion for building elite clinical execution inside a startup environment, apply now to be part of our dedicated team. 

Job Location: Remote (Houston, Texas preferred)

Does this sound like you?

• 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.

In this role, you will:

Clinical Oversight & Trial Execution

• 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 on time, within budget, and in compliance with applicable regulations.

Regulatory Strategy & Compliance

• Lead regulatory strategy and execution, including IDE and other submissions applicable to future products.
• Represent Motif directly with FDA and other regulatory bodies, including pre-submission meetings.
• Own post-market surveillance and regulatory compliance obligations, including adverse event reporting and any post-approval study commitments.

Team & Department Leadership

• Directly manage clinical and regulatory personnel including hiring, onboarding, training, performance management, and team building.
• Build out the clinical and regulatory affairs departments, functions, and teams as Motif scales.

Cross-Functional Partnership & Representation

• Partner closely with cross-functional teams to ensure study design supports product development and approval  and reimbursement/market access strategy.
• Advise R&D during design and development to ensure regulatory requirements are considered early in products.
• Identify, engage, and build relationships with global and regional KOLs to guide clinical strategy and strengthen program credibility.
• Represent the Clinical and Regulatory department internally at Motif.
• Represent Motif externally at clinical sites, industry conferences, meetings, and from the podium.
• Serve as the regulatory subject matter expert during audits and inspections, working alongside our quality leader
• Serve as the connective tissue and strategic communicator linking clinical to the executive, marketing, technical, and operations teams to work as one unit.
• Travel to Houston, Texas for meetings at headquarters as needed and to conferences, meetings, and clinical sites. 

This is not an exhaustive list of duties and you may be asked to perform different tasks if your role within or the objectives of the organization changes.

To be considered, you must have:

• 12+ years of experience spanning clinical and regulatory functions at a medical device company specialized in active implantables, with at least 4 years focus in neuromodulation or implantable BCI devices
• 6+ years of experience partnering with cross-functional teams on study design that supports product development and approval strategy
• 6+ years of experience managing clinical trial budgets, resources, timelines, and risk, with a track record of on-time, in-budget delivery
• 5+ years of experience directly managing clinical and/or regulatory teams
• Demonstrated experience leading a multi-function clinical department
• Demonstrated experience leading regulatory strategy and submissions for implantable neuromodulation devices, including direct interaction with the FDA (pre-submission meetings, IDE submissions, etc.)
• Direct, hands-on ownership of a multi-site clinical trial from site activation through study close-out
• Comfort operating in a small company or startup environment, including personally executing tactical, in-the-weeds work
• A track record of representing an organization at clinical sites, clinical meetings, and similar venues
• Proven success managing CROs, specialized vendors, and consultants to execute industry-sponsored trials
• Working knowledge of GCP, ISO 14155, and applicable device regulatory requirements.
• A history of fostering and maintaining relationships with KOLs

It is a bonus if you have:

• Experience overseeing or managing a clinical science function, including evidence strategy, endpoint selection, statistical analysis plans, and data interpretation
• An existing network of KOLs in neurology, neurosurgery, psychiatry, or related fields.

Work Authorization Notice

Motif Neurotech hires only individuals who are authorized to work in the United States. At this time, visa sponsorship is not offered for this role

Note: Level and title for this role will be determined based on experience.