The Director, 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. You must have IVD, POC or medical device (not pharmaceuticals) clinical affairs experience to be considered.
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
$20% performance based annual bonus
401K company match
Flexible medical, dental, and vision coverage
