Oversight Director, Clinical Operations (Biotech)

Location: Hybrid role based in South San Francisco, California, United States; willingness to travel up to 30% is required.

Salary: $232,000–$283,000 annual base salary for employees located in the San Francisco Bay Area, 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 development assets from protocol development through study closeout and regulatory readiness.
• Oversee multiple global clinical studies, including enrollment, feasibility, country and site strategies, milestones, timelines, quality, and operational risk management.
• Lead CRO and vendor strategy, governance, performance management, escalations, budgets, work orders, and contract-related discussions.
• Maintain accountability for clinical operations budgets, forecasting, resource planning, and operational capacity across the assigned asset.
• Ensure inspection readiness and compliance with SOPs, ICH-GCP, FDA, EMA, and other applicable regulatory requirements.
• Advance scalable processes and implement clinical operations systems such as eTMF, CTMS, and RBM platforms, including AI/ML-enabled approaches.

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 trials and oversight of development assets.
• Experience leading, coaching, and developing Clinical Operations teams, including Study Leads and other clinical operations professionals.
• Deep knowledge of global clinical trial operations, FDA, EMA, ICH-GCP, inspection readiness, and regulatory requirements.
• Experience managing CRO and vendor partnerships, complex clinical trial budgets, forecasting, resource planning, and operational risks.
• Strong communication, collaboration, strategic planning, and cross-functional leadership skills.

Culture & Benefits

• Collaborative biotech environment focused on precision medicines and patient impact.
• Supportive culture encouraging initiative, creative thinking, talent development, and freedom of expression.
• Medical, dental, vision, and mental health benefits for eligible employees.
• Equity incentive plan and 401(k) program with employer match.
• Generous holiday and paid time off policy.