Oncology Clinical Ops Compliance Director
Exelixis
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Job summary
Exelixis is seeking a Clinical Operations Compliance Director to lead risk, issue, CAPA, and vendor oversight for oncology trials. You will partner with Quality Assurance and cross‑functional teams to ensure adherence to ICH GCP and global regulations, shaping inspection readiness and continuous process improvements.
The role requires extensive biotech/pharma experience, strong leadership, and the ability to influence without direct authority across Clinical Operations, Data Management,
Qualifications
- Bachelor’s degree with 13+ years of related experience; or Master’s with 11+; or Doctoral with 8+.
- Experience in biotech/pharmaceutical industry required, including CROs, R&D outsourcing, purchasing, or procurement roles.
- Leadership and management experience with external vendors and teams.
Responsibilities
- Lead the Clinical Operations risk and issue management program for compliant study conduct.
- Partner with Clinical Operations and cross‑functional leaders to identify, assess, mitigate, and accelerate risks.
- Develop and implement functional risk management strategies and annual risk plans for inspection readiness.
- Review trends, quality metrics, and inspection readiness measures with functional leadership.
- Oversee CAPAs with ownership, tracking, and effectiveness evaluation; report status to leadership.
Skills
Education
Tools
Job description
Exelixis is seeking a Clinical Operations Compliance Director to lead risk, issue, CAPA, and vendor oversight for oncology trials. You will partner with Quality Assurance and cross‑functional teams to ensure adherence to ICH GCP and global regulations, shaping inspection readiness and continuous process improvements.
The role requires extensive biotech/pharma experience, strong leadership, and the ability to influence without direct authority across Clinical Operations, Data Management,
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