Senior Director, Clinical Operations Compliance Management (Biotechnology/Oncology)

The Senior Director, Clinical Operations Compliance Management (COCM) is responsible for ensuring that clinical research activities are conducted in accordance with ICH GCP, international and local regulations, requirements and guidelines, as well as Exelixis written standards. Key activities include focus on risk management, issue management, vendor oversight and site and data monitoring.

Requirements

• Leadership of risk and issue management process for Clinical Operations
• Provide trends and other relevant reporting to Process Owners and Clinical Operations and/or appropriate Leadership Teams
• Define strategy and methodology for functional risk/issue management
• Provide support to Clinical Operations CAPA owners
• Work closely with and act as liaison for Quality Assurance team and other functional teams across R&D and beyond

Benefits

• 401k plan with generous company contributions
• Group medical, dental and vision coverage
• Life and disability insurance
• Flexible spending accounts
• Discretionary annual bonus program
• Sales-based incentive plan
• Opportunity to purchase company stock
• Long-term incentives