Director, Clinical Affairs

Description

About Spryte Medical, we're advancing the future of neurovascular care by developing breakthrough imaging technology that gives physicians greater insight when every decision matters. Our mission is to empower physicians with the clarity and confidence they need to improve patient outcomes and redefine what's possible in patient care.

Joining Spryte means becoming part of a growing team driven by innovation, collaboration, and purpose. We believe great ideas come from people who are curious, hands-on, and passionate about solving meaningful challenges. Here, your work won't get lost in a large organization—it will help shape our technology, our culture, and the future of our company.

If you're looking for an opportunity to make a visible impact while helping bring transformative technology to physicians and patients, we'd love to hear from you.

Spryte Medical is seeking an experienced and highly motivated Director, Clinical Affairs to provide strategic and operational leadership for the Company's clinical research activities. This individual will be responsible for the planning, execution, oversight, and continuous improvement of clinical studies supporting regulatory submissions, product development, and post-market evidence generation.

The Director of Clinical Affairs will ensure all clinical investigations are conducted in compliance with applicable regulations, ICH-GCP guidelines, ISO 14155, company procedures, and study protocols. This role will serve as a key cross-functional leader, collaborating closely with Regulatory Affairs, Customer Experience, Quality, R&D, Biostatistics, Medical Affairs, and Executive Management to deliver high-quality clinical evidence supporting the Company's business and regulatory objectives.

As the organization grows, this leader will be responsible for building and developing the Clinical Affairs function, including talent acquisition, mentoring, resource planning, and vendor management.

• Provide strategic leadership for clinical programs supporting product development, regulatory submissions, and post-market evidence generation.
• Develop and execute clinical development plans aligned with corporate and regulatory objectives.
• Serve as the clinical operations subject matter expert for management and cross-functional teams.
• Identify program risks, develop mitigation strategies, and elevate critical issues to executive leadership as appropriate.
• Establish and continuously improve clinical processes, systems, metrics, and best practices to support organizational growth.

• Lead all phases of clinical investigations from planning through study closeout.
• Oversee the development and review of clinical protocols, informed consent forms, case report forms, monitoring plans, statistical analysis plans, study reports, and related study documentation.
• Ensure clinical studies are conducted in accordance with ICH-GCP, ISO 14155, applicable regulations, company SOPs, and investigational plans.
• Own study timelines, budgets, enrollment performance, study milestones, and reporting metrics.
• Ensure inspection readiness and compliance across all clinical programs.

• Lead site feasibility, selection, activation, management, and closeout activities.
• Develop and maintain strong relationships with investigators, study coordinators, key opinion leaders, and research institutions.
• Select, onboard, manage, and evaluate CROs, consultants, data management providers, central laboratories, and other clinical vendors.
• Establish vendor performance expectations and ensure delivery of high-quality services within budget and timeline commitments.
• Chair clinical team meetings and…