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