Director, IVD Clinical Affairs & Strategy

HealthCare Recruiters International; Boston (MA); Hybrid; USD 180,000 - 240,000; Full time

Job summary

HealthCare Recruiters International seeks a Director of Clinical Affairs to lead strategy, study planning, execution, and evidence generation for IVD/POC products. Hybrid role, with 3-5 onsite days weekly in the Greater Boston area.

You will manage complex clinical programs, collaborate with Regulatory, R&D, Quality, and Marketing, and drive data integrity while mentoring the team and coordinating external partners and vendors.

Qualifications

• 10-15+ years of experience in the IVD 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.
• Experience developing and managing Key Opinion Leader relationships.
• Familiarity with ISO 14155, ISO 20916, or ICH E6.

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.

Skills

IVD experience

POC/medical device experience

clinical trials management

publications & conferences

KOL relationships

cross-functional collaboration

Job description

HealthCare Recruiters International seeks a Director of Clinical Affairs to lead strategy, study planning, execution, and evidence generation for IVD/POC products. Hybrid role, with 3-5 onsite days weekly in the Greater Boston area.

You will manage complex clinical programs, collaborate with Regulatory, R&D, Quality, and Marketing, and drive data integrity while mentoring the team and coordinating external partners and vendors.