Clinical Operations Compliance Director

Job Summary

Providing strategic leadership in compliance, the full-time Clinical Operations Compliance Director will ensure oncology clinical research activities adhere to regulations and industry standards while managing risk, issue oversight, and inspection readiness in a remote environment.

Key responsibilities

• Lead the execution and improvement of the Clinical Operations risk and issue management program
• Collaborate with Clinical Operations and cross-functional teams to assess and mitigate risks impacting clinical trial quality and compliance
• Drive consistency in clinical trial execution through the development and implementation of standardized processes and best practices

Required qualifications

• Bachelor's degree in a related discipline with a minimum of 13 years of experience, or a Master's degree with 11 years, or a Doctoral degree with 8 years of experience
• Experience in the biotech or pharmaceutical industry, including roles with CROs and R&D outsourcing
• Demonstrated leadership and management skills in a relevant industry role
• In-depth knowledge of biopharmaceutical industry regulations and best practices
• Strong analytical and strategic thinking skills with the ability to adapt in a fast-paced environment