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
Compensation: - Base Pay: $240,000-$280,000 per year
- Annual Bonus Eligibility
