Clinical Affairs Lead

Location: Office-based in Massachusetts (currently Concord) or California (Irvine or San Diego). California offices require in-person work 5 days a week; the Massachusetts office requires in-person work 2–3 days a week. Travel up to 20% is required, including visits to other offices and industry conferences.

Salary: $120,000+ annually, based on experience

Company

hirify.global is a medical technology company developing diabetes management solutions, including the iLet Bionic Pancreas.

What you will do

• Coordinate and support investigator-initiated and sponsor-initiated clinical research studies.
• Assess adverse events for relatedness, expectedness, seriousness, and severity using device data and study documentation.
• Draft clinical study protocols, consent forms, study manuals, safety management plans, reports, abstracts, posters, and presentations.
• Assess clinical sites, train study staff and participants, conduct site initiation visits, and manage day-to-day site operations.
• Provide clinical guidance for commercial products, device complaints, off-label use inquiries, and healthcare-provider communications.
• Support audits, corrective and preventive actions, standard operating procedures, and compliance with clinical research regulations.

Requirements

• Bachelor of Science degree and clinical licensure as an RN, NP, RD, PA, or RPh.
• At least 5 years of clinical experience in diabetes and at least 5 years of clinical research experience.
• Experience drafting clinical documents, protocols, study manuals, abstracts, presentations, and posters.
• Knowledge of medical device clinical requirements, US regulations, ICH GCP, and ISO 14155.
• Experience with ethics committee or IRB submissions, US IDE submissions, and related requirements.
• Proficiency with Microsoft Office, Adobe Acrobat, and Salesforce, with strong communication, organization, attention to detail, and collaboration skills.

Nice to have

• Master’s degree.
• CDCES or BC-ADM certification.
• Clinical research certification such as CRN-BC or CCRP.
• Experience in both inpatient and outpatient diabetes management.

Culture & Benefits

• Mission-driven, collaborative environment with significant ownership and impact.
• Comprehensive medical and dental coverage.
• FSA and HSA options, including an annual company HSA contribution.
• 401(k) program with employer match.
• Vacation accrual and paid holidays.