Director, Clinical Affairs

Paylocity; Bedford (MA); On-site; USD 215,000 - 230,000; Full time

Job summary

Spryte Medical is seeking an experienced Director, Clinical Affairs to provide strategic and operational leadership for the company's clinical research activities. This role encompasses planning, execution, oversight, and continuous improvement of clinical studies supporting regulatory submissions and product development.

The Director will ensure compliance with ICH-GCP, ISO 14155, and FDA regulations, collaborate with Regulatory Affairs, Quality, R&D, and Biostatistics, and build the Clinical

Qualifications

• Bachelor's degree in Life Sciences, Nursing, Biomedical Engineering, Public Health, or related field.
• 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.

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.
• Own study timelines, budgets, enrollment performance, study milestones, and reporting metrics.
• Oversee Trial Master File (TMF) completeness and inspection readiness.
• Collaborate with Regulatory Affairs to support regulatory submissions and regulatory agency responses.

Skills

Clinical leadership

Cross-functional collaboration

Regulatory knowledge

Leadership experience

Education

Bachelor's degree in Life Sciences

Job description

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.

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.

Essential Responsibilities

Clinical Strategy & Leadership

• 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.

Clinical Study Management

• 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.

Site & Vendor Oversight

• 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.

Clinical Quality & Compliance

• 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.

Regulatory Support

• 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.

People Leadership

• 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.

Experience & Qualifications

• 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.

Preferred

• 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.

Equal Employment Opportunity

Spryte Medical is an Equal Opportunity Employer committed to building a diverse and inclusive workplace where everyone is respected, valued, and has the opportunity to succeed. We make all employment decisions based on qualifications, merit, and business needs, and do not discriminate on the basis of race, color, religion, creed, sex, pregnancy, childbirth or related medical conditions, sexual orientation, gender identity or expression, national origin, ancestry, age, disability, genetic information, marital status, military or veteran status, or any other characteristic protected by applicable federal, state, or local law.

We are committed to providing reasonable accommodations to qualified individuals with disabilities and to applicants throughout the hiring process. If you require accommodation to participate in the application or interview process, please let us know.

Salary Description

$215k-$230k