Oversight Director, Clinical Operations

Location: South San Francisco, California, United States; hybrid. Travel of up to 30% is required to support study needs.

Salary: $232,000–$283,000 annual base salary, plus eligibility for an annual performance bonus.

Company

hirify.global is a clinical-stage biopharmaceutical company developing precision medicines for kidney and metabolic diseases through human genetics and small-molecule programs.

What you will do

• Provide strategic and operational direction across CKD and PKU clinical development assets from protocol development through study closeout and regulatory readiness.
• Oversee multiple global Phase I–III studies, including enrollment, feasibility, site strategy, milestones, timelines, quality, and operational risk management.
• Develop CRO and vendor strategies, oversee governance and performance, and manage escalations, budgets, contracts, and change orders.
• Maintain financial accountability, forecasting, resource planning, inspection readiness, and compliance with SOPs, ICH-GCP, and regulatory requirements.
• Implement scalable clinical operations processes, systems, and technologies including eTMF, CTMS, RBM platforms, and AI/ML-enabled solutions.
• Lead cross-functional collaboration and coach Study Leads and Clinical Operations professionals.

Requirements

• Bachelor’s degree in a scientific or health-related field.
• 12–15+ years of progressive clinical operations experience, including leadership of global Phase I–III clinical trials and oversight of development assets.
• Experience managing Clinical Operations teams, including direct management, coaching, and mentoring.
• Deep knowledge of FDA, EMA, ICH-GCP, and other applicable regulatory requirements, with a record of maintaining inspection readiness.
• Extensive CRO and vendor management experience, including governance, negotiations, budget accountability, forecasting, and resource planning.
• Strong communication, collaboration, strategic planning, risk management, and senior stakeholder influence skills.

Culture & Benefits

• Collaborative biotech environment focused on precision medicines and patient impact.
• Culture emphasizing resilience, initiative, integrity, teamwork, and talent development.
• Medical, dental, and vision insurance, including mental health offerings.
• Equity incentive plan and 401(k) program with employer match.
• Generous holiday and paid time off policy.