Clinical Operations Compliance Director (Biotechnology Oncology)

Location: Alameda, California, United States

Salary: $179,500–$256,000 annually, depending on geographic market and qualifications.

Company

hirify.global is a biotechnology company developing oncology medicines and conducting clinical research.

What you will do

• Lead and continuously improve Clinical Operations risk and issue management programs.
• Identify, assess, mitigate, and escalate risks affecting clinical trial quality, compliance, and execution.
• Oversee CAPAs, compliance metrics, quality trends, key risk indicators, and inspection-readiness measures.
• Partner with Quality Assurance on audits, regulatory inspections, mock inspections, follow-up actions, and health authority responses.
• Drive standardized clinical trial processes, templates, best practices, and cross-study consistency.
• Oversee CRO and clinical vendor performance, monitoring quality, risk-based monitoring signals, and site or data issues.

Requirements

• Bachelor’s degree with at least 13 years of related experience, master’s degree with at least 11 years, doctoral degree with at least 8 years, or an equivalent combination.
• Biotech or pharmaceutical industry experience, including CROs, R&D outsourcing, purchasing, or procurement roles.
• Experience leading teams and engaging with external suppliers.
• In-depth knowledge of biopharmaceutical regulations, standards, best practices, and the external scientific, legal, and regulatory environment.
• Strong leadership, communication, analytical, strategic thinking, problem-solving, organizational, presentation, and influencing skills.
• Advanced knowledge of Microsoft Excel, Word, PowerPoint, and Outlook.

Nice to have

• Expertise in training, capability development, and Clinical Operations analytics.
• Experience with BIMO, TMF inspection readiness, mock inspections, RBQM/RBM, or monitoring oversight.

Culture & Benefits

• Collaborative office environment designed for close teamwork and idea sharing.
• Equipment includes dual monitors and ergonomic chairs.
• Comprehensive employee benefits, including 401(k) contributions, medical, dental, and vision coverage, life and disability insurance, and flexible spending accounts.
• Annual bonus eligibility, stock purchase opportunities, and long-term incentives.
• Paid vacation, company holidays, winter shutdown, and sick days.