Clinical Operations Compliance Lead - Oncology Trials

Exelixis Inc; Alameda (CA); Hybrid; USD 169,000 - 239,000; Full time

Benefits offered by this job

401k contributions

Medical coverage

Dental coverage

Vision coverage

Life and disability insurance

Discretionary annual bonus

Job summary

Exelixis Inc. is seeking an Associate Clinical Operations Compliance Director to support oncology clinical research under ICH GCP and applicable regulations.

You will focus on risk/issue management, vendor oversight, and site/data monitoring while partnering with QA and other groups to ensure inspection readiness across studies. The role requires deep regulatory and industry knowledge, strong analytical and communication skills, and leadership in cross‑functional collaboration to drive quality

Qualifications

• Broad knowledge of biopharmaceutical industry regulations, standards and best practices.
• Experience in biotech/pharmaceutical industry.
• Proven ability to work with cross-functional teams and manage CAPA processes.

Responsibilities

• Support risk and issue management for Clinical Operations and contribute to functional risk management plans.
• Assist CAPA owners with assignments, follow‑up and closure; monitor CAPA completion.
• Collaborate with Quality Assurance and other functions to maintain inspection readiness across studies.

Skills

Regulatory knowledge

Analytical thinking

Strategic thinking

Project management

Communication skills

Cross-functional collaboration

Presentation skills

Education

Bachelor’s degree

Master’s degree

Doctoral degree

Tools

Microsoft Excel

Microsoft Word

PowerPoint

Outlook

Job description

Exelixis Inc. is seeking an Associate Clinical Operations Compliance Director to support oncology clinical research under ICH GCP and applicable regulations.

You will focus on risk/issue management, vendor oversight, and site/data monitoring while partnering with QA and other groups to ensure inspection readiness across studies. The role requires deep regulatory and industry knowledge, strong analytical and communication skills, and leadership in cross‑functional collaboration to drive quality