Head of Clinical

Co-Founder @ Neura Worx | Medical Devices for Brain Health

Head of Clinical

Company: Neuraworx Medical Technologies, Inc.

Position Type: Full-Time, Hands-On Clinical Leadership

Location: Minneapolis, MN (Hybrid/Remote considered)

Reports to: CEO/Cofounder

We are an innovative seed-stage medical device startup developing a wearable neurostimulation device for traumatic brain injury (TBI) and other CNS disorders. With feasibility studies launched and product development progressing, we seek a hands‑on clinical leader to guide end‑to‑end clinical strategy and execution.

The Head of Clinical is the architect and project lead for all clinical activities. This high‑impact role blends clinical study design, operational management, and strategic oversight. You will bring our novel technology from concept into NSR human pilot trials, working closely with executive leadership, scientific advisors, external partners, and regulatory bodies to deliver clinical evidence.

• Design, plan, and execute clinical trials—including protocol authorship, case report form design, and IRB support documentation.
• Serve as the primary liaison for the Scientific Advisory Board; coordinate meetings, prepare content, and document outcomes.
• Report progress toward clinical/regulatory milestones to executives and investors.
• Define the clinical roadmap and critical path milestones to support the company’s broader commercialization strategy.

• Lead day‑to‑day clinical trial operations: recruitment, site onboarding, scheduling, sample logistics, data collection, and monitoring (including travel).
• Manage relationships research sites, reference labs, and fractional consultants.
• Coordinate, clean, and review all clinical data for traceability and regulatory readiness.
• Ensure trials are executed on time and within budget while maintaining high data integrity.

• Own regulatory-facing deliverables (IRB/FDA submissions) and ensure continuous compliance with all relevant regulations and guidelines.
• Support the company’s Quality Management System (QMS), maintaining alignment with ISO 13485 and GCP.
• Oversee risk management, CAPA investigations, and adverse event reporting in accordance with device regulations.

• Build and lead a high‑performance clinical team as the company grows.
• Foster a culture of compliance, patient safety, and scientific rigor.
• Communicate complex clinical concepts to non‑clinical stakeholders including engineers, investors, and board members.

• BS or MS in a life science, biomedical engineering, nursing, or regulatory/quality discipline.
• 7+ years’ progressive clinical research experience, preferably including hands‑on trial management for medical devices in the US.
• Track record of developing protocols, authoring IRB and FDA submissions, and operating in lean, cross‑functional environments.
• Broad knowledge of medical device GCP, ISO 13485, 21 CFR Part 820, and QMS operations.
• Demonstrated leadership, communication, and problem‑solving skills in a fast‑moving, multidisciplinary setting.
• Entrepreneurial mindset: comfort with ambiguity, ability to prioritize effectively with limited resources, and enthusiasm for building something from the ground up.

• Experience with Scientific Advisory Boards or KOL engagement.
• Wearable medical device experience or network.
• Experience with neuromodulation, TBI, or CNS disorders.
• Prior startup or early‑stage company experience.
• Experience with sleep studies.
• Experience in clinical, regulatory, quality.
• Familiarity with electronic data capture (EDC) systems and clinical data management best practices.

• Operational depth with strategic breadth: You can design the high‑level strategy but are also able/interested in hands‑on site calls and document review.
• Intellectual humility: Willingness to learn unfamiliar domains and seek expertise from others.
• Bias toward action: Comfortable making decisions with imperfect information; avoids analysis paralysis.
• Collaborative problem‑solver: Enjoys working across…