Director Of Clinical Research (Medtech)

TL;DR

Director of Clinical Research (Medtech): Leading and managing all aspects of clinical study activities to support product development and commercial growth with an accent on GCP compliance, study design, and KOL management. Focus on driving clinical evidence for ultrasound-on-chip technology and AI-powered medical imaging solutions.

Location: Must be based in or able to work from the San Francisco Bay Area or New York City, NY (Hybrid)

Salary: $230,000 - $245,000 + bonus + equity

Company

hirify.global is a digital health company revolutionizing ultrasound imaging through proprietary semiconductor technology, AI, and cloud-based software solutions.

What you will do

• Lead company-sponsored clinical studies in compliance with GCP standards.
• Design clinical study protocols and statistical plans in collaboration with cross-functional teams.
• Manage the Investigator Initiated Trials (IIT) program, including proposal assessment and contract development.
• Serve as the Clinical Science Liaison to recruit and manage KOLs and external research partners.
• Mentor clinical team members and manage departmental staffing and budget priorities.
• Analyze clinical and scientific data to support pre-market and post-market product performance.

Requirements

• Must be legally authorized to work in the United States without sponsorship.
• BS degree in Engineering or a Technical Field (PhD, MD, or equivalent preferred).
• 7-10 years of experience in the medical device or healthcare industry.
• At least 6 years of experience in clinical affairs or clinical trial management.
• Strong knowledge of GCP, IRB/Ethics Committee requirements, and clinical study design.
• Established network of KOLs and clinical research collaborators.

Nice to have

• Experience with AI/ML or Software as a Medical Device (SaMD).
• Familiarity with ultrasound imaging.
• Experience with regulatory authority audits.

Culture & Benefits

• Comprehensive health insurance including dental and vision, plus HSA contributions.
• 401k plan with company match.
• Unlimited Paid Time Off and 10 paid holidays per year.
• Employee Stock Purchase Plan (ESPP) and equity participation.
• Parental leave and comprehensive Employee Assistance Program.
• Collaborative hybrid work environment with stocked kitchens and modern workspaces.