Director, Clinical Affairs

Spryte Medical•Bedford, MA

8d•$215,000 - $230,000

About The Position

About Spryte Medical At 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. The Opportunity 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.

Requirements

Bachelor's degree in Life Sciences, Nursing, Biomedical Engineering, Public Health, or related scientific discipline.
Minimum 10 years of progressive clinical research and clinical operations experience within the medical device industry.
Minimum 3 years of leadership experience, including direct management or functional leadership of clinical personnel and/or CROs.
Demonstrated experience managing multicenter clinical studies from study design through study closeout.
Thorough knowledge of: ICH-GCP, ISO 14155, FDA regulations, Medical device clinical investigations, Clinical trial quality management systems.
Experience managing CROs, clinical vendors, budgets, and timelines.
Strong project management, organizational, and analytical skills.
Excellent verbal, written, and presentation skills.
Proven ability to influence cross-functional teams and drive execution in a fast-paced environment.

Nice To Haves

Master's degree or advanced clinical/scientific degree.
Experience supporting IDE, De Novo, PMA, and/or global regulatory submissions.
Experience in neurovascular, neurology, cardiovascular, or other Class III medical device clinical programs.
ACRP, SOCRA, CCRP, CCRA, or equivalent certification.
Startup or high-growth medical device company experience.

Responsibilities

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 escalate 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 provide leadership across internal and external stakeholders.
Oversee Trial Master File (TMF) completeness and inspection readiness.
Ensure appropriate oversight of monitoring activities and data quality processes.
Review and support resolution of data listings, protocol deviations, queries, and study-related issues.
Ensure compliance with applicable regulations, standards, and company procedures.
Support audits, inspections, and regulatory authority interactions as needed.
Collaborate with Regulatory Affairs to support IDEs, De Novo submissions, PMAs, 510(k)s, MDR submissions, and other global regulatory activities.
Ensure clinical documentation is complete, accurate, and submission-ready.
Support responses to regulatory agency questions and clinical evidence requests.
Recruit, develop, mentor, and retain Clinical Affairs personnel.
Establish individual and departmental objectives aligned with company goals.
Foster a culture of accountability, collaboration, quality, and continuous improvement.
Provide coaching and leadership to cross-functional project teams.