Senior Director, Clinical Operations Compliance & Risk

Regulatory Jobs; United States; On-site; USD 246,000 - 350,000; Full time

Benefits offered by this job

401k plan

Medical, dental, vision insurance

Life and disability insurance

Flexible spending accounts

Annual bonus program

Stock options

Paid vacation and holidays

Job summary

Exelixis is seeking a Senior Director of Clinical Operations Compliance Management to lead risk and issue management, drive inspection readiness, and standardize cross-functional processes across R&D. This role collaborates with QA and Clinical Development to ensure compliant study execution.

The ideal candidate brings extensive biotech/pharma experience, senior leadership skills, and a proactive, data-driven approach to improve governance and vendor oversight.

Qualifications

• Education requirements: bachelor’s or higher in related field with extensive experience.
• Experience: 15+ years in biotech/pharma; leadership at senior level with external suppliers.
• Regulatory knowledge: deep understanding of biopharmaceutical regs and standards.

Responsibilities

• Lead risk and issue management for Clinical Operations compliance.
• Provide trends and reporting to Process Owners and Leadership; drive improvements.
• Define strategy for functional risk/issue management; ensure inspection readiness.

Skills

Leadership

Strategic thinking

Communication

Influencing

Analytical thinking

Time management

Change management

Organizational skills

Presentation skills

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 is seeking a Senior Director of Clinical Operations Compliance Management to lead risk and issue management, drive inspection readiness, and standardize cross-functional processes across R&D. This role collaborates with QA and Clinical Development to ensure compliant study execution.

The ideal candidate brings extensive biotech/pharma experience, senior leadership skills, and a proactive, data-driven approach to improve governance and vendor oversight.