Oncology Clinical Operations Compliance Director

Exelixis Inc; Alameda (CA); On-site; USD 180,000 - 256,000; Full time

Benefits offered by this job

401k plan with company contributions

Group medical coverage

Dental coverage

Vision coverage

Life insurance

Disability insurance

Discretionary annual bonus program

Company stock purchase option

Long-term incentives

15 vacation days in first year

17 paid holidays

Job summary

Exelixis Inc seeks a Clinical Operations Compliance Director to lead risk, issue and CAPA programs for oncology trials. The role partners with QA and cross-functional teams to ensure GCP compliance, inspection readiness and continuous process improvement across the development portfolio.

Responsibilities include governance of risk strategies, vendor oversight and data-driven quality metrics, with heavy collaboration with R&D leadership. Strong leadership and regulatory knowledge are essential.

Qualifications

• Education requirements: Bachelor’s degree and 13+ years experience; or Master’s degree and 11+ years; or Doctoral degree and 8+ years; or equivalent combo.
• Experience in biotech/pharmaceutical industry required; leadership and management experience with external suppliers.
• Strong communication, collaboration, and analytical skills; ability to work independently in fast-paced environment.

Responsibilities

• Lead the execution and continuous improvement of the Clinical Operations risk and issue management program.
• Partner with Clinical Operations leadership to identify, assess, mitigate and accelerate risks affecting quality and execution.
• Develop and implement functional risk management strategies and annual plans for inspection readiness.
• Communicate compliance trends and metrics to leadership.
• Oversee CAPAs and ensure timely completion and effectiveness evaluation.
• Collaborate with Quality Assurance for audits and regulatory inspections.
• Drive standardized processes, templates and best practices across trials.
• Identify and resolve significant operational and quality issues and escalate as needed.
• Oversee clinical vendors and CRO partnerships to meet quality/compliance expectations.

Skills

Leadership

Risk management

Issue management

CAPA oversight

Vendor oversight

Inspection readiness

Cross-functional collaboration

Regulatory knowledge

Data analysis

Strategic thinking

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 risk, issue and CAPA programs for oncology trials. The role partners with QA and cross-functional teams to ensure GCP compliance, inspection readiness and continuous process improvement across the development portfolio.

Responsibilities include governance of risk strategies, vendor oversight and data-driven quality metrics, with heavy collaboration with R&D leadership. Strong leadership and regulatory knowledge are essential.