Remote Associate Director, Clinical Operations Compliance

Exelixis Inc.; United States; Remote; USD 190,000 - 241,000; Full time

Benefits offered by this job

401k plan with generous company/conhem

group medical, dental and vision

life and disability insurance

flexible spending accounts

discretionary annual bonus program

stock purchase program

long-term incentives

vacation days and holidays

sick days

Job summary

Exelixis Inc. is seeking an Associate Clinical Operations Compliance Director to enhance oncology clinical research by adhering to ICH GCP and international regulations. You will focus on risk/issue management, vendor oversight, site monitoring, and data integrity while partnering with QA and Clinical Development teams.

This role supports inspection readiness and cross-study consistency across processes. The position emphasizes training, analytics, BIMO/inspection readiness, and RBQM oversight.

Qualifications

• Bachelor’s degree with 11+ years of related experience; Master’s with 9+; Doctoral with 5+; or equivalent combo.
• Experience in biotech/pharmaceutical industry and regulatory environment.
• Strong knowledge of biopharmaceutical industry regulations, standards and best practices.

Responsibilities

• Support risk and issue management for Clinical Operations ensuring compliant study delivery.
• Contribute to risk management strategy and annual functional risk plan for inspection readiness.
• Support CAPA owners with assignments, follow-up and closure.
• Assist updates on CAPA completion data and remediation.
• Act as liaison with QA and other R&D functions; ensure cross-functional collaboration.
• Manage areas: Training & Analytics, Inspection Readiness, RBQM/RBM & Monitoring Oversight.

Skills

GCP compliance knowledge

Risk & issue management

CAPA management

Inspection readiness

Cross-functional collaboration

Vendor oversight

Data monitoring oversight

Executive communication

Excel/Office proficiency

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

Word

PowerPoint

Job description

Exelixis Inc. is seeking an Associate Clinical Operations Compliance Director to enhance oncology clinical research by adhering to ICH GCP and international regulations. You will focus on risk/issue management, vendor oversight, site monitoring, and data integrity while partnering with QA and Clinical Development teams.

This role supports inspection readiness and cross-study consistency across processes. The position emphasizes training, analytics, BIMO/inspection readiness, and RBQM oversight.