Hiring: Director, Clinical Affairs Company: Noctrix Health, Inc. Location: Pleasanton, CA Job Posted Time: 2026-09-12 10:18:47 Employment Type: Full-time / Hybrid Target Skills & Keywords : GCP, User Experience About the job Experience: •8 years of clinical affairs or clinical research experience within the medical device industry Required Skills: •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 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 •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 •In-depth knowledge 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 Compensation: •$240,000 - $280,000 / year Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!