Clinical Operations Manager (Gene Therapy)

Location: Somerville, Massachusetts, United States

Salary: $164,000–$199,000 USD per year, plus annual incentive bonus and equity grants

Company

hirify.global is a biotechnology company developing Gene Writing™ technologies intended to introduce therapeutic messages into the genome and address diseases at their source.

What you will do

• Lead cross-functional clinical study teams and manage global clinical trials from start-up through closeout, including first-in-human to Phase 3 programs.
• Develop and manage study strategies, budgets, timelines, operational plans, and clinical supplies forecasting.
• Select, contract with, and oversee CROs and third-party vendors, ensuring delivery against study plans, scope, quality standards, and metrics.
• Oversee site feasibility, evaluation, and selection, while supporting investigator relationships and patient recruitment and retention strategies.
• Review and develop clinical study documents, including protocols, informed consent forms, investigator brochures, clinical study reports, case report forms, and regulatory submissions.
• Identify and mitigate study risks, manage data quality and compliance, maintain inspection readiness, and oversee TMF, database lock, reconciliation, and closeout activities.

Requirements

• Bachelor’s degree in a relevant scientific or healthcare discipline and 8+ years of clinical operations experience, including 4+ years as a clinical trial manager.
• Experience managing global clinical operations, CROs, vendors, budgets, and timelines across the full clinical trial lifecycle.
• In-depth knowledge of ICH/GCP guidelines and working knowledge of regulatory guidelines and directives.
• Proficiency with trial management systems, IVRS/IWRS, eTMF, EDC, SmartSheets, Microsoft Project, PowerPoint, Word, and Excel.
• Strong project management, cross-functional leadership, prioritization, organization, and issue-escalation skills.
• Ability to work in a fast-paced environment and adapt to changing program needs.

Nice to have

• Current rare disease and/or gene therapy experience.
• FDA and other regulatory inspection experience.

Culture & Benefits

• Creative and collaborative environment focused on scientific excellence and integrity.
• Medical, vision, and dental coverage.
• Group life and disability insurance.
• 401(k) plan with company contribution.
• Tuition reimbursement and additional benefits supporting employee and family health, wellness, and financial security.