Director, Clinical Affairs — IVD Trials & Regulatory Strategy

novabio; Waltham (MA); Hybrid; USD 184,000 - 235,000; Full time

Benefits offered by this job

Hybrid work arrangements

Medical, dental, and vision coverage

401(k) company match

Bonus program

Tuition reimbursement

Professional development

Job summary

Nova Biomedical is seeking a Director of Clinical Affairs to lead clinical strategy, planning, and evidence generation for in vitro diagnostic and point-of-care products. This role oversees trials, post-market activities, and regulatory submissions to ensure timelines, budgets, and quality standards are met.

The successful candidate will manage site selection, study execution, and cross-functional collaboration with R&D, Quality, Manufacturing, and Regulatory teams, while advancing data

Qualifications

• 10–15+ years in the IVD sector
• Experience with point-of-care and critical care tech
• Experience managing or performing clinical trials
• Experience preparing scientific publications and presenting at conferences
• Experience developing and managing Key Opinion Leader relationships
• Familiarity with 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 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 to support efficiency and data integrity
• Represent Clinical Affairs in leadership discussions and provide updates, risk assessments, and recommendations

Skills

Clinical affairs leadership

Clinical trials management

Regulatory compliance

KOL relationships

Scientific publications

ISO/ICH knowledge

Cross-functional collaboration

Job description

Nova Biomedical is seeking a Director of Clinical Affairs to lead clinical strategy, planning, and evidence generation for in vitro diagnostic and point-of-care products. This role oversees trials, post-market activities, and regulatory submissions to ensure timelines, budgets, and quality standards are met.

The successful candidate will manage site selection, study execution, and cross-functional collaboration with R&D, Quality, Manufacturing, and Regulatory teams, while advancing data