Director, Clinical Affairs.

Nova Biomedical • Waltham, MA

2d • Hybrid

About The Position

The Director, Clinical Affairs leads the Clinical Affairs function for in vitro diagnostic and point-of-care products. The role is responsible for clinical strategy, study planning and execution, and clinical evidence generation. It oversees clinical performance studies and post-market activities that support regulatory submissions, product development, and lifecycle management while ensuring compliance with regulatory requirements, timelines, budgets, and quality standards.

The Director manages Clinical Affairs personnel and external partners, and collaborates with Regulatory Affairs, R&D, Quality, Manufacturing, Medical/Scientific, and Marketing. The position is based in Waltham, Massachusetts, with an on-site schedule of 3–5 days per week and on-site/remote arrangements. The targeted base salary range is $184,000–$235,000.

Requirements

• 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 or seminars.
• Experience developing and managing Key Opinion Leader relationships.
• Familiarity with international clinical standards and regulations, including ISO 14155, ISO 20196, 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 management of 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.

Benefits

• Flexible medical, dental, and vision coverage.
• Competitive 401(k) company match.
• Bonus program.
• Generous paid time off and paid holidays.
• Tuition reimbursement.
• Hybrid and flexible work arrangements.
• Professional development, engagement, and events.
• Company marketplace for lunch and snacks at the Norwood, Billerica, and Westbrook offices.
• Company-subsidized cafeteria at the Waltham office.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: No Education Listed