Oncology Clinical Operations Compliance Lead

Exelixis; Alameda (CA); On-site; USD 169,000 - 239,000; Full time

Benefits offered by this job

401k plan

Medical coverage

Stock options

Discretionary bonus

Vacation & holidays

Job summary

Exelixis is seeking an Associate Clinical Operations Compliance Director to support oncology clinical research in line with ICH GCP and local regulations. The role partners with QA and other functions to ensure inspection readiness, cross-study consistency, and escalation of operational quality issues.

A strong background in biopharma regulations and risk management is required. Responsibilities include developing risk management strategies, supporting CAPA processes, and monitoring CRO

Qualifications

• Bachelor's degree in related discipline with 11+ years of related experience; or
• Master's degree with 9+ years; or
• Doctoral degree with 5+ years; or equivalent combination of education and experience.

Responsibilities

• Support risk and issue management for compliant study delivery.
• Help create annual functional risk management plan for inspection readiness.
• Support CAPA owners with follow-up and closure.
• Assist CAPA data updates (late/near due/due later).
• Coordinate with QA and other R&D functions to escalate issues.

Skills

Biopharmaceutical regulations

Analytical thinking

Communication skills

Project management

Collaboration

Independence

Problem-solving

Time management

Attention to detail

Microsoft Excel

Presentation skills

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 Word

PowerPoint

Outlook

Job description

Exelixis is seeking an Associate Clinical Operations Compliance Director to support oncology clinical research in line with ICH GCP and local regulations. The role partners with QA and other functions to ensure inspection readiness, cross-study consistency, and escalation of operational quality issues.

A strong background in biopharma regulations and risk management is required. Responsibilities include developing risk management strategies, supporting CAPA processes, and monitoring CRO