Strategic Oncology Clinical Operations Compliance Director

Exelixis, Inc.

Alameda, Northern (CA, KY)

Hybrid

USD 180,000 - 256,000

Full time

14 days+

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Benefits offered by this job

401k plan

Group medical coverage

Dental coverage

Vision coverage

Life insurance

Disability insurance

Flexible spending accounts

Discretionary annual bonus

Stock purchase option

Long-term incentives

Vacation days

Holidays

Sick days

Job summary

Exelixis, Inc. is seeking a Clinical Operations Compliance Director in Alameda, CA to lead risk and issue management for oncology trials. You will partner with QA and cross-functional teams to advance compliant study execution and proactive quality improvements.

You will drive CAPA oversight, inspection readiness activities, and vendor governance while promoting standardized processes and metrics. Strong leadership, strategic thinking, and a deep regulatory knowledge are essential for success.

Qualifications

Bachelor's degree in related discipline; 13+ years in biotech/pharma or equivalent.
Experience in biotech/pharma with CROs, outsourcing, or procurement roles.
Demonstrated leadership and team management in an external-supplier environment.
Ability to communicate with executives and cross-functional partners.

Responsibilities

Lead and improve Clinical Operations risk and issue management to ensure compliant study conduct.
Partner with Clinical Operations and cross-functional teams to mitigate risks affecting quality and execution.
Develop and implement risk management, CAPA oversight, and inspection readiness programs.
Provide data-driven updates on trends, risks and CAPA effectiveness to leadership.
Oversee vendor and CRO relationships to ensure quality and compliance across studies.