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

Role Summary

The Senior Director, Clinical Operations Compliance Management (COCM) is responsible for ensuring that clinical research activities are conducted in accordance with ICH GCP and applicable regulations and Exelixis standards. The role focuses on risk and issue management, vendor oversight, and site and data monitoring, and collaborates with Quality Assurance and other functional groups to support inspection readiness and cross-study consistency in study execution and compliance. The position also drives standardization of processes and templates and supports system improvements used by Clinical Operations.

Responsibilities

• Leadership of risk and issue management process for Clinical Operations focusing on compliant delivery of study execution.
• Provide trends and reporting to Process Owners and Leadership Teams and translate trends into process improvements and risk-based decisions.
• Define strategy and methodology for functional risk/issue management, create annual risk management plans to ensure inspection readiness, review outcomes, and collaborate cross-functionally on risk activities.
• Provide support to CAPA owners, including assignment, follow-up and completion.
• Provide development leadership with updates on CAPA completion data (late, near due, due later).
• Coordinate with Quality Assurance and other functional teams across R&D and beyond.

Qualifications

• Bachelor‚Äôs degree in a related discipline with a minimum of 15 years of related experience; or Master‚Äôs degree with 13 years; or Doctoral degree with 12 years; or equivalent combination of education and experience.
• Typically requires a minimum of 15 years of related experience and/or combination of education/training and experience.
• Experience in biotech/pharmaceutical industry required; experience with CROs, R&D outsourcing, purchasing or procurement roles preferred.
• Demonstrated leadership and management experience in a senior role involving engagement with external suppliers.
• Strong understanding of external scientific, legal and regulatory environment; prior team leadership experience.

Education

• Bachelor‚Äôs degree in related discipline; or higher degrees as listed in Qualifications.

Skills

• Leadership and networking
• Communication and engagement
• Partnership and collaboration
• Influencing across a complex supplier landscape
• In-depth knowledge of biopharmaceutical regulations, standards and best practices
• Effective verbal and written communication; formal presentation skills
• Self-starter, fast learner, strong collaborator with ability to work independently
• Analytical, strategic thinking, problem-solving, time management, change management, and organizational skills
• Interpersonal, verbal and written communication; attention to detail
• Ability to identify and communicate issues and risks; excellent presentation skills
• Relationship-building and influence without direct authority
• Proficiency in Microsoft Excel, Word, PowerPoint, and Outlook
• Alignment with company values and the ability to drive changes in ways of working
• Ability to streamline processes to minimize burden on business owners
• Experience embedding a risk and issue management framework

Additional Requirements

• Occasional travel (less than 10%) to current and/or prospective vendor facilities.