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Senior Clinical Program Director

Jobright.ai, Houston, Texas, United States, 77246

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Jobright.ai Jobright is an AI-powered career platform that helps job seekers discover the top opportunities in the US. We are NOT a staffing agency. Jobright does not hire directly for these positions. We connect you with verified openings from employers you can trust. Job Summary: Motif Neurotech is a medical device startup focused on developing innovative solutions for mental health conditions. They are seeking a Clinical Program Director to design and execute strategies for clinical evidence generation that supports regulatory approval and product validation, while collaborating with cross-functional teams and external partners. Responsibilities: • Develop and maintain global clinical evidence plans aligned with therapy objectives, product development milestones, and regulatory requirements. • Create and manage multi-year evidence roadmaps addressing both pre-market and post-market study needs. • Design clinical studies that support product claims, regulatory submissions, and long-term therapy adoption. • Lead execution of industry-sponsored clinical trials in collaboration with CROs, specialized vendors, and consultants. • Oversee study design, site strategy, patient recruitment, and data quality to meet regulatory and product performance goals. • Manage timelines, budgets, and operational risks with proactive mitigation strategies. • Ensure studies are delivered on time, within budget, and in compliance with GCP, ISO 14155, and applicable regulations. • Work closely with Leadership, Market Access, Regulatory, R&D teams to ensure study design supports product development and approval strategies. • Collaborate with clinical scientists and biostatisticians on endpoint selection, statistical analysis plans, and data interpretation. • Identify, engage, and develop relationships with global and regional KOLs to guide clinical strategy and enhance program credibility. • Partner with KOLs to refine study design, endpoints, and recruitment strategies. • Foster long-term KOL relationships to support ongoing evidence generation, scientific exchange, and therapy adoption. Qualifications: Required: • Bachelor's degree in engineering, science, health science, nursing, or related field. • 10+ years of experience leading clinical research programs in the medical device industry, including study management. • Proven success designing and executing industry-sponsored clinical trials in implantable medical devices or interventional psychiatry that achieved regulatory or launch milestones. • Strong experience in identification, development, and management of medical professionals and KOLs. • Experience managing CRO and multiple vendors. • Familiarity with device regulations, GCP, and ISO 14155. Company: Motif Neurotech is a company that develops minimally invasive bioelectronic implants for monitoring and treating severe mental illnesses. Founded in 2022, the company is headquartered in Houston, Texas, USA, with a team of 11-50 employees. The company is currently Early Stage. Seniority level

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