Director of Clinical Affairs

Leads the Clinical Affairs function for in vitro diagnostic and point-of-care products, with responsibility for clinical strategy, study planning, execution, and clinical evidence generation. Oversees clinical performance studies and post-market activities supporting regulatory submissions, product development, and lifecycle management while ensuring compliance with regulatory requirements, timelines, budgets, and quality standards.

Note this is a hybrid opportunity requiring 3-5 days/week onsite at a Greater Boston location.

Responsibilities

• Develop and lead clinical affairs strategy aligned with product development, regulatory, and post-market evidence needs
• Lead clinical study design, planning, execution, monitoring, and reporting including timelines, budgets, and risks
• Develop, review, and approve clinical study documentation including protocols, reports, and regulatory support materials
• Oversee clinical site selection, start-up, conduct, and close-out ensuring data quality and compliance
• Ensure studies comply with applicable regulations, standards, and internal procedures
• Manage Clinical Affairs personnel, external partners, and vendors while supporting team development
• Partner with Regulatory Affairs to support submissions and clinical evidence requirements
• Collaborate cross-functionally with R&D, Quality, Manufacturing, Medical/Scientific, and Marketing
• Improve clinical processes, metrics, and governance practices to support efficiency and data integrity
• Represent Clinical Affairs in leadership discussions and provide updates, risk assessments, and recommendations

Experience & Requirements

• 10-15+ years of experience in the IVD (in vitro diagnostics) sector
• Experience with point-of-care and critical care technologies
• Experience managing or performing clinical trials and evaluations
• Experience preparing scientific publications and presenting at conferences or seminars
• Experience developing and managing Key Opinion Leader relationships
• Familiarity with international clinical standards and regulations including ISO 14155, ISO 20916, or ICH E6

Compensation & Benefits

• $225,000-$235,000 salary
• $20% performance based annual bonus
• 401K company match
• Flexible medical, dental, and vision coverage
• Tuition assistance
• PTO, paid holidays