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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

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Product Management

• Industries

  Software Development

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Inferred from the description for this job

Medical insurance

Vision insurance

401(k)

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