---
title: 'Director, Clinical Affairs at Noctrix Health'
canonical: 'https://feeny.ai/job/director-clinical-affairs-noctrix-health-pleasanton-d2z573r6sg9t'
type: 'job'
last_seen: '2026-09-11'
---

# Director, Clinical Affairs at Noctrix Health

- **Company:** Noctrix Health
- **Location:** Pleasanton, CA
- **Posted:** 2026-08-13
- **Last confirmed live:** 2026-09-11
- **Apply:** https://job-boards.greenhouse.io/noctrixhealth/jobs/5388543008

## Job description

Noctrix Health is redefining the treatment of chronic neurological disorders with clinically validated therapeutic wearables. Our team of medical device specialists, neuroscientists, and consumer electronics engineers is dedicated to delivering prescription-grade therapy with an outstanding user experience. We have pioneered the world’s first drug-free wearable therapy, clinically proven to alleviate symptoms in adults with drug-resistant Restless Legs Syndrome (RLS). Join us in transforming healthcare, improving lives, and driving meaningful change through innovative medical technology.

We are seeking an experienced and strategic Director, Clinical Affairs to lead the planning, execution, and oversight of clinical studies supporting the development, regulatory approval, reimbursement, and commercialization of Noctrix Health’s medical devices. This leader will be accountable for the successful delivery of clinical programs, ensuring studies are executed efficiently, compliantly, on schedule, and within budget while generating high-quality clinical evidence that supports regulatory and business objectives.

The Director, Clinical Affairs will serve as a key cross-functional leader and liaison among Clinical Affairs, Clinical Research, Regulatory Affairs, Quality, Product Development, and external partners. This individual will provide leadership across clinical operations, including sponsor oversight, site management, CRO and vendor management, clinical data quality, study execution, and evidence generation.

This position reports to the Senior Vice President, Clinical & Regulatory Affairs.

This is a full-time, hybrid position that is located at our Pleasanton headquarters.

Responsibilities:

- Lead the planning, execution, and oversight of medical device clinical studies from study start-up through close-out
- Contribute to clinical development strategies supporting product development, regulatory submissions, reimbursement initiatives, commercialization, and post-market evidence generation
- Provide effective sponsor oversight of clinical trials, including monitoring activities, site performance, protocol compliance, enrollment, and clinical data quality
- Ensure clinical studies are conducted in accordance with applicable FDA requirements, Good Clinical Practice (GCP), ISO 14155, approved protocols, and company procedures
- Develop and manage study timelines, budgets, resource plans, enrollment forecasts, and key milestones
- Proactively identify clinical program risks, develop mitigation strategies, and resolve operational challenges that could impact study timelines, quality, or budget
- Lead clinical site identification, selection, initiation, engagement, performance management, and close-out activities
- Build and maintain productive relationships with investigators, study coordinators, research institutions, and other clinical partners
- Select, manage, and oversee CROs, clinical vendors, consultants, and service providers to ensure quality, timeline, and budget expectations are achieved
- Support the development and review of clinical study protocols, informed consent forms, case report forms, clinical reports, and other study documentation
- Partner with Regulatory Affairs to support regulatory submissions requiring clinical evidence and ensure clinical programs are aligned with regulatory strategy
- Ensure the integrity, completeness, quality, and traceability of clinical data and study documentation
- Support adverse event review, safety monitoring, clinical risk management, audits, regulatory inspections, and applicable Quality System activities
- Collaborate with Product Development, Quality, Regulatory Affairs, and Clinical Research to incorporate clinical insights into product development, risk management, labeling, and post-market activities
- Support the generation of clinical evidence for reimbursement, payer engagement, market access, and commercialization initiatives
- Establish and monitor clinical program KPIs, study performance metrics, and operational dashboards
- Provide executive leadership with regular updates regarding study progress, enrollment, budgets, risks, clinical evidence generation, and key program milestones
- Lead, mentor, and develop Clinical Affairs personnel while establishing clear performance expectations and promoting operational excellence
- Identify and implement opportunities to improve clinical processes, systems, vendor management, and study execution as the organization scales

Requirements:

- Bachelor’s degree in Nursing, Life Sciences, Biomedical Engineering, or a related scientific or technical discipline
- Minimum of 8 years of clinical affairs or clinical research experience within the medical device industry
- Demonstrated leadership experience managing Clinical Affairs personnel, CROs, clinical vendors, and external partners
- Proven experience managing medical device clinical programs from study start-up through execution and close-out
- Experience with multiple clinical study models, including multicenter, decentralized, and hybrid clinical trials
- Strong knowledge of FDA clinical trial requirements, Good Clinical Practice (ICH-GCP), ISO 14155, and applicable clinical research regulations
- Demonstrated experience providing sponsor oversight of medical device clinical studies
- Experience developing and managing clinical study budgets, timelines, enrollment forecasts, resources, and operational plans
- Experience supporting clinical evidence generation for regulatory submissions
- Strong understanding of clinical study documentation, data quality, safety reporting, monitoring, and inspection-readiness requirements
- Proven ability to identify and mitigate clinical program risks while managing multiple priorities and studies simultaneously
- Excellent leadership, project management, organizational, and problem-solving capabilities
- Strong written and verbal communication skills with the ability to communicate clinical strategy, study performance, and risks to executive leadership
- Demonstrated ability to effectively collaborate across Clinical Research, Regulatory Affairs, Quality, Product Development, and other functions

Preferred Qualifications:

- Master’s degree or other advanced degree in a relevant scientific, clinical, or technical discipline
- Experience within a startup or growth-stage medical device organization
- Experience supporting pivotal or other clinical studies used for FDA submissions and product approvals/clearances
- Experience generating clinical evidence to support reimbursement, payer coverage, or market access initiatives
- Experience with neurological, neuromodulation, wearable, or connected medical devices
- Experience supporting FDA inspections, clinical site audits, and other regulatory or Quality System inspections
- Experience building or scaling Clinical Affairs functions, processes, and teams
- Experience working with international clinical studies and regulatory requirements

Compensation:

- Base Pay: $240,000–$280,000 per year
- Annual Bonus Eligibility

## About Noctrix Health

## Company Overview
- **One-liner**: Noctrix Health develops clinically validated wearable neuromodulation devices as non-pharmaceutical alternatives for managing chronic neurological disorders, starting with Restless Legs Syndrome (RLS).
- **Entity Type**: Private (Acquired by ResMed in May 2026 for $340M)
- **Headquarters**: Pleasanton, California, United States
- **Founded**: 2018
- **Founders**: Jonathan Charlesworth (CSO), Justin Kelly (SVP, Product), Steve Lien (SVP, Patient Access), Shriram Raghunathan (CEO)

## Core Business
- **Primary industry/industries**: Medical Device Manufacturing, Neuromodulation, Wearable Therapeutics, Sleep Health
- **Target customers**: B2B (healthcare providers, sleep clinics, DMEs) and B2C (patients with Restless Legs Syndrome)
- **Mission or purpose statement**: To innovate the next generation of clinically-validated wearable therapeutics to address the unmet needs of millions of people living with chronic medical conditions.

## Products & Services
- **[Nidra® Therapy (TOMAC Therapy)]**: A prescription wearable device that delivers Tonic Motor Activation (TOMAC) therapy to treat Restless Legs Syndrome (RLS). It is a non-pharmaceutical, clinically validated alternative that uses neuromodulation to alleviate symptoms without disrupting sleep. The therapy has received favorable inclusion in the American Academy of Sleep Medicine (AASM) clinical practice guidelines and has dedicated CMS reimbursement codes.

## Market Standing
- **Valuation/Market Cap**: Acquired by ResMed for $340 million (announced May 6, 2026).
- **Key Metric**: Total funding raised was approximately $57M (per CB Insights) to $107.2M (per LinkedIn), with the most recent round being a Series C - II. Annual revenue is estimated at $2.5M (pre-acquisition).
- **Notable Investors/Partners**: ResMed (acquirer), OrbiMed, Treo Ventures, The Blue Venture Fund, Sandbox Industries, Bridge Bank.
- **Growth Signals**: Headcount grew 100% YoY to 110 employees. The company secured dedicated CMS reimbursement codes for Nidra therapy. The therapy was included in new AASM clinical practice guidelines for RLS. The company was acquired by ResMed for $340M in May 2026, signaling strong validation and a major growth trajectory.

## Competitive Advantages
- **First-to-market with a non-pharmaceutical wearable for RLS**: Nidra therapy is a clinically validated, drug-free alternative for a condition affecting ~7% of adults globally, offering a significant differentiator in a market dominated by pharmaceuticals.
- **Strong clinical and regulatory moat**: The therapy has been included in AASM clinical practice guidelines and has dedicated CMS reimbursement codes, creating high barriers to entry for competitors.
- **Backed by ResMed**: The $340M acquisition by the global leader in sleep health provides immense resources, distribution channels, and market credibility.

## Strategic Focus
- **Post-acquisition scaling**: Following the acquisition by ResMed, the primary focus is on rapidly scaling U.S. commercialization, expanding market access, and integrating Nidra therapy into ResMed's global sleep health portfolio.
- **Expanding indications**: While currently focused on RLS, the company's platform technology has potential for treating other chronic neurological disorders.
- **Building the commercial engine**: The company is actively hiring across sales, marketing, patient access, and engineering roles to support its growth.

## Why Work Here
- **Patient-centered mission**: The company is deeply mission-driven, with a culture that prioritizes improving patient lives. Employees describe a strong sense of purpose in delivering life-changing therapy.
- **High-growth environment**: With 100% YoY headcount growth, a recent $340M acquisition, and 50+ open roles, this is a fast-scaling company with significant career advancement opportunities.
- **Culture of transparency and problem-solving**: The company emphasizes core values like "embrace the unknown," "build trust through transparency," and "win as a team," fostering a collaborative and innovative environment.
- **Remote-friendly**: Many roles are listed as remote, including sales, patient access, and support positions, though some engineering and marketing roles are based in Pleasanton, CA, or Pittsburgh, PA.
- **Strong engineering and clinical culture**: The team is a mix of seasoned medical device experts, neuroscientists, and engineers from the consumer electronics world, offering a unique blend of high-tech and life-science work.

## Sources
1. [noctrixhealth.com](https://noctrixhealth.com/)
2. [noctrixhealth.com/careers](https://noctrixhealth.com/careers/)
3. [greenhouse.io](http://job-boards.greenhouse.io/noctrixhealth)
4. [linkedin.com](https://www.linkedin.com/company/noctrix-health)
5. [cbinsights.com](https://www.cbinsights.com/company/noctrix-health)

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