Director, Clinical Affairs

The role

The Director, Clinical Affairs will lead the planning, execution, and oversight of medical device clinical studies. This role supports product development, regulatory approval, reimbursement, and commercialization.

What you will do

• 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, and commercialization
• Provide sponsor oversight of clinical trials including monitoring, site performance, and data quality
• Ensure studies follow FDA requirements, Good Clinical Practice, and ISO 14155
• Develop and manage study timelines, budgets, resource plans, and enrollment forecasts
• Identify clinical program risks and develop mitigation strategies
• Lead clinical site identification, selection, and management
• Select and manage CROs, clinical vendors, consultants, and service providers
• Support the development and review of clinical study protocols and documentation
• Partner with Regulatory Affairs to support regulatory submissions

Required qualifications

• 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

Nice to have

• 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

About the company

Noctrix Health is redefining the treatment of chronic neurological disorders with clinically validated therapeutic wearables. The team is dedicated to delivering prescription-grade therapy with an outstanding user experience.