Remote Oncology Clinical Operations Compliance Director

Exelixis Inc.; United States; Remote; USD 202,000 - 256,000; Full time

Job summary

Exelixis Inc. seeks a Clinical Operations Compliance Director to lead compliance across oncology clinical research in line with ICH GCP and global regulations.

You will guide risk management, CAPA oversight, vendor oversight, and inspection readiness while partnering with QA and R&D stakeholders. The role emphasizes strategic and operational leadership, development of standardized processes, and proactive data-driven quality improvements across the clinical development portfolio.

Qualifications

• Bachelor's degree in related discipline and minimum of 13 years of related experience, or
• Master's degree and minimum of 11 years of related experience, or
• Doctoral degree and minimum of 8 years of related experience, or
• Equivalent combination of education and experience.

Responsibilities

• Lead the implementation and continuous improvement of risk and issue management for compliant study conduct.
• Partner with Clinical Operations and cross-functional teams to identify, assess, mitigate and elevate risks impacting trial quality and compliance.
• Develop and execute functional risk management strategies and annual risk plans to support inspection readiness.
• Communicate compliance trends, metrics and inspection readiness to leadership.
• Oversee CAPA processes with ownership, tracking and effectiveness evaluation.
• Provide updates and recommendations on CAPA status, risks, trends and issues to leadership.
• Collaborate with Quality Assurance for audits, inspections and follow-up actions.
• Drive standardized processes, templates and best practices for cross-study consistency.
• Identify and escalate significant operational/quality issues through governance structures.
• Oversee clinical vendors and CRO partnerships to ensure quality and compliance.
• Use data to identify opportunities for process improvement and risk reduction.
• Serve as SME for Clinical Operations compliance processes and provide guidance and training.

Skills

Leadership

Risk management

Regulatory knowledge

GCP/ICH

CAPA oversight

Vendor oversight

Inspection readiness

Data analysis

Training & mentoring

Cross-functional collaboration

Education

Bachelor's degree in related discipline

Master's degree in related discipline

Doctoral degree in related discipline

Equivalent combination of education and experience

Tools

Microsoft Excel

Microsoft Word

PowerPoint

Outlook

Job description

Exelixis Inc. seeks a Clinical Operations Compliance Director to lead compliance across oncology clinical research in line with ICH GCP and global regulations.

You will guide risk management, CAPA oversight, vendor oversight, and inspection readiness while partnering with QA and R&D stakeholders. The role emphasizes strategic and operational leadership, development of standardized processes, and proactive data-driven quality improvements across the clinical development portfolio.