Head of Clinical

NeuraWorx; Minneapolis (MN); Hybrid; USD 180.000 - 240.000; Vollzeit

Benefits dieser Stelle

Equity ownership

Collaborative culture

Growth trajectory

Zusammenfassung

A cutting-edge medical device startup is seeking a Head of Clinical to lead the clinical strategy for a neurostimulation device targeting traumatic brain injury. This role encompasses designing clinical trials, managing day-to-day operations, and ensuring regulatory compliance. Ideal candidates will have 7+ years in clinical research for medical devices and a strong educational background in life sciences. If you thrive in a fast-paced environment and are eager to shape clinical evidence, apply now!

Qualifikationen

• 7+ years of progressive clinical research experience in medical devices.
• Track record of developing protocols, IRB, and FDA submissions.
• Broad knowledge of GCP, ISO 13485, and QMS operations.
• Knowledge of GCP, ISO 13485, 21 CFR Part 820, and QMS operations.
• Proven leadership, communication, and problem-solving in fast-moving settings.
• Entrepreneurial mindset with ability to navigate ambiguity.

Aufgaben

• Design, plan, and execute clinical trials, including protocol authorship.
• Lead day-to-day clinical trial operations including recruitment and data collection.
• Own regulatory-facing deliverables and ensure compliance.
• Own regulatory deliverables and ensure ongoing compliance with relevant regulations.

Kenntnisse

Hands-on trial management

Leadership

Problem-solving

Communication

Operational management

Startup experience

EDC systems

QMS familiarity

Ausbildung

BS or MS in life science, biomedical engineering, nursing, or regulatory/quality discipline

Tools

EDC systems

Quality Management System (QMS)

Jobbeschreibung

Co-Founder @ NeuraWorx | 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

Position Overview

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.

Key Responsibilities

Strategic Leadership & Study Design

• 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.

Clinical Operations & Execution

• 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.

Regulatory & Quality Compliance

• 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.

Team Building & Culture

• 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.

Required Qualifications

• 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.

Preferred Qualifications

• 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.

What We're Looking For

• 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 disciplines (Engineering, Regulatory, Business) and bringing different perspectives together.
• Translational thinker: Able to understand engineering constraints, translate them to clinical possibilities, and explain clinical realities to business stakeholders.
• Hands‑on leadership: Wants to stay engaged in the details of the trials, not just delegate.

What We Offer

• Significant hands‑on work: You’ll spend ~60% of your time actively managing clinical execution, ~40% on leadership, strategy, and cross‑functional alignment.
• Equity ownership: Meaningful equity stake reflecting your pivotal role in shaping the company’s clinical success.
• Growth trajectory: Clear advancement path as the company scales.
• Resources & autonomy: Freedom to help build the clinical function the right way from the ground up; budget and decision‑making authority commensurate with the role.
• Impactful mission: Develop technology that could meaningfully improve patients’ lives; avoid “me‑too” products in favor of genuine innovation.
• Collaborative culture: Work directly with CEO and co‑founders who value clinical input in strategic decisions.
• Learning environment: Access to leading neurotech experts, clinical sites, and clinical advisors; opportunity to deepen expertise across multiple domains.

How to Apply

Send resumes to [e-mail]

• Tell us about your most significant clinical trial challenge and how you solved it.
• Describe your experience managing clinical sites—what worked well, and what didn’t?
• What aspects of TBI/CNS clinical studies or neurostimulation excite or intrigue you most?

About the Role's Evolution

• This is a founding position, and its scope will evolve. Initially, you will be the primary clinical resource, reporting directly to the CEO/Cofounder. As we grow and initiate larger studies, you may help build a team of specialized clinical staff (CRAs, Clinical Project Managers). Success in this role is defined by the quality of clinical evidence delivered and regulatory milestones achieved, not by headcount managed.