About the Job
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 ...
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 deliv...
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, ...
Key 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
Required Skills & Abilities
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
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
