Director, Clinical Affairs

The posting, as Noctrix Health wrote it

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

[…]

• 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: $230,000–$250,000 per year
• Annual Bonus Eligibility