Director, Clinical Affairs (IVD)

Location: Waltham, Massachusetts, United States; hybrid schedule with 3–5 days per week on-site/remote

Targeted salary range: $184,000–$235,000 per year

Company

hirify.global develops in vitro diagnostic and point-of-care instrumentation and scientific solutions for biopharmaceutical and clinical markets.

What you will do

• Develop and lead Clinical Affairs strategy aligned with product development, regulatory submissions, and post-market evidence needs.
• Design, plan, execute, monitor, and report clinical studies while managing timelines, budgets, risks, and data quality.
• Prepare, review, and approve clinical study protocols, reports, publications, and regulatory support materials.
• Oversee clinical site selection, start-up, study conduct, and close-out in accordance with applicable requirements.
• Manage Clinical Affairs personnel, external partners, vendors, and Key Opinion Leader relationships.
• Collaborate with Regulatory Affairs, R&D, Quality, Manufacturing, Medical/Scientific, and Marketing teams.

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.
• Familiarity with international clinical standards and regulations, including ISO 14155, ISO 20196, or ICH E6.
• Ability to work on-site in Waltham, Massachusetts, 3–5 days per week, and communicate effectively by phone, video, and in writing.

Culture & Benefits

• Hybrid and flexible work arrangements.
• Medical, dental, and vision coverage.
• 401(k) company match, bonus program, generous paid time off, and paid holidays.
• Tuition reimbursement and professional development opportunities.
• Lunch and snack marketplace at selected offices and a subsidized cafeteria at the Waltham office.