Director, Clinical Affairs

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-