Director, Clinical Operations (Biopharma)

Location: Hybrid role in South San Francisco, California, United States; travel of up to 30% may be required to support study needs.

Salary: $232,000–$283,000 annual 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

• Lead operational execution of a complex global pivotal Phase 3 chronic kidney disease study from protocol development and start-up through enrollment, database lock, closeout, submission support, and inspection readiness.
• Translate protocol requirements into executable plans, monitor milestones and quality indicators, and identify and mitigate emerging operational risks.
• Lead the Study Execution Team and coordinate Clinical Science, Regulatory Affairs, Biostatistics, Data Management, Safety, Quality, CMC, and Supply Chain stakeholders.
• Oversee CRO, vendor, and site strategies, including governance, performance metrics, escalation pathways, corrective actions, budgets, and scope changes.
• Maintain accountability for the global study budget, including forecasting, accruals, variance analysis, change control, and long-range planning.
• Drive inspection readiness, compliance, process optimization, and adoption of data-informed and AI/ML-enabled Clinical Operations technologies.

Requirements

• Bachelor’s degree in a scientific or health-related field.
• 10–12+ years of clinical operations experience, including leadership of Phase I–III trials.
• Demonstrated end-to-end operational leadership of a complex global Phase 3 study.
• Experience managing and developing teams through coaching, mentoring, delegation, and professional growth support.
• Expertise in global regulatory requirements, including FDA, EMA, ANVISA, AMA, and ICH-GCP, with direct audit and inspection-readiness experience.
• Strong strategic judgment, communication, facilitation, collaboration, conflict-resolution, and executive influencing skills, plus experience in a hands-on biotech environment.

Nice to have

• Clinical trial experience in renal or cardiometabolic diseases.
• Experience with risk-based monitoring, advanced data insights, or AI/ML-enabled solutions.

Culture & Benefits

• Collaborative biotech environment focused on scientific excellence and patient impact.
• Culture built around resilience, teamwork, bold decision-making, integrity, and talent development.
• Medical, dental, vision, and mental health benefits for eligible employees.
• Equity incentive plan, 401(k) with employer match, generous holidays, and paid time off.