Director of Clinical Affairs, Medical Devices

Noctrix Health, Inc.; Pleasanton (CA); Hybrid; USD 180,000 - 260,000; Full time

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Strategic leadership

Clinical operations

Vendor management

FDA compliance

Study budgeting

Cross-functional collaboration

Education

Bachelor's degree

Master's degree

Job description

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.