Senior Director, Clinical Ops Compliance & Risk Management

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

Job summary

Exelixis is seeking a Senior Director, Clinical Operations Compliance Management to ensure compliant study conduct across GLPs and GCPs within a complex vendor landscape.

The role emphasizes cross-functional collaboration with QA, Clinical Development, and Data Management to standardize processes, drive risk management, and readiness for inspections. Extensive leadership and regulatory acumen are required.

Qualifications

• Minimum 15 years of related experience in biotech/pharmaceutical sectors.
• Experience with CROs, R&D outsourcing, purchasing or procurement roles.
• Proven leadership of teams and collaboration with external suppliers.
• Fluency in current regulatory environments and industry standards.

Responsibilities

• Lead risk and issue management for Clinical Operations with compliant study delivery.
• Provide trends and reporting to leadership and enable process improvements.
• Define strategy for functional risk/issue management and inspection readiness.
• Support CAPA owners and maintain CAPA data visibility.
• Collaborate with Quality Assurance and other R&D functions.

Skills

Leadership

Communication

Stakeholder management

Regulatory knowledge

Risk & issue management

Cross-functional collaboration

Influencing without authority

Analytical thinking

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

PowerPoint

Word

Outlook

Job description

Exelixis is seeking a Senior Director, Clinical Operations Compliance Management to ensure compliant study conduct across GLPs and GCPs within a complex vendor landscape.

The role emphasizes cross-functional collaboration with QA, Clinical Development, and Data Management to standardize processes, drive risk management, and readiness for inspections. Extensive leadership and regulatory acumen are required.