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