Director, Clinical Affairs

Noctrix Health, Inc.; Pleasanton (CA); Híbrido; USD 180 000 - 260 000; Tempo integral

Resumo da oferta

Noctrix Health, Inc. seeks a Director of Clinical Affairs to lead planning, execution, and oversight of clinical studies supporting regulatory approval and commercialization of its drug-free wearable therapies.

You will coordinate across Clinical Affairs, Regulatory, Quality, Product Development, and external partners, ensuring trials meet FDA, GCP, and ISO 14155 standards in a hybrid, Pleasanton-based role.

Qualificações

• Bachelor’s degree in Nursing, Life Sciences, Biomedical Engineering, or related field.
• Minimum of 8 years in clinical affairs or clinical research in the medical device industry (explicit).
• Leadership experience managing Clinical Affairs personnel, CROs, and external partners.
• Experience managing medical device clinical programs from start-up through close-out.
• Knowledge of multiple clinical study models (multicenter, decentralized, hybrid).
• Strong knowledge of FDA clinical trial requirements, ICH-GCP, ISO 14155, and related regs.
• Experience providing sponsor oversight of medical device clinical studies.
• Budgeting, timeline planning, resources, and operational plans experience.
• Ability to support regulatory submissions with clinical evidence.

Responsabilidades

• Lead the planning, execution, and oversight of medical device clinical studies from start-up through close-out.
• Contribute to clinical development strategies supporting regulatory submissions, reimbursement, and commercialization.
• Provide sponsor oversight of trials including monitoring, site performance, protocol compliance, enrollment, and data quality.
• Ensure studies comply with FDA, GCP, ISO 14155, approved protocols, and company procedures.
• Develop and manage study timelines, budgets, resource plans, enrollment forecasts, and milestones.
• Identify risks, develop mitigations, and resolve operational challenges affecting timelines, quality, or budget.
• Lead site identification, initiation, engagement, performance management, and close-out activities.
• Build relationships with investigators, research institutions, and clinical partners.
• Oversee CROs, vendors, consultants, and service providers to meet quality and budget goals.
• Support study protocol development, consent forms, CRFs, and clinical reports.
• Partner with Regulatory Affairs to align clinical programs with regulatory strategy.
• Ensure data integrity, quality, and traceability of study documentation.
• Support adverse event review, safety monitoring, audits, inspections, and quality system activities.
• Collaborate with Product Development, Quality, Regulatory, and Clinical Research on incorporating clinical insights.
• Support evidence generation for reimbursement, payer engagement, and market access.
• Establish and monitor KPIs, study performance metrics, and dashboards.
• Provide executives with updates on progress, enrollment, budgets, risks, and milestones.
• Mentor and develop Clinical Affairs staff and promote operational excellence.
• Identify opportunities to improve clinical processes, systems, and vendor management as the organization grows.

Conhecimentos

Strategic leadership

Clinical operations

Vendor management

FDA compliance

Study budgeting

Cross-functional collaboration

Formação académica

Bachelor's degree

Master's degree

Descrição da oferta de emprego

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