Clinical Operations Compliance & Risk Director

Exelixis; Alameda (CA); On-site; USD 246,000 - 350,000; Full time

Benefits offered by this job

401k plan

Medical/Dental/Vision coverage

Life Insurance

Discretionary bonus

Stock options

Vacation days

Job summary

Exelixis, based in Alameda, CA, seeks a Senior Director of Clinical Operations Compliance Management to lead risk and issue management, strengthen inspection readiness, and drive cross-functional process improvements within the Clinical Operations function.

The role requires extensive biotech/pharma experience, strong regulatory acumen, and proven leadership of senior teams. Occasional travel (<10%) is expected.

Qualifications

• 15+ years of related experience in biotech/pharma, with senior leadership.

Responsibilities

• Lead risk and issue management for Clinical Operations to ensure compliant study delivery.
• Provide trends and reporting to Process Owners and Leadership to enable improvements.
• Define strategy and annual plan for functional risk/issue management and inspection readiness.
• Support CAPA owners with assignment, follow-up and closure.
• Coordinate with QA and other functional teams across R&D and beyond.

Skills

Leadership

Risk management

Regulatory knowledge

Cross-functional collaboration

Communication

Project management

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, based in Alameda, CA, seeks a Senior Director of Clinical Operations Compliance Management to lead risk and issue management, strengthen inspection readiness, and drive cross-functional process improvements within the Clinical Operations function.

The role requires extensive biotech/pharma experience, strong regulatory acumen, and proven leadership of senior teams. Occasional travel (<10%) is expected.