Senior Director, Clinical Compliance 
Location: South San Francisco, California, United States

About the Role
A growing biopharmaceutical company is seeking a Senior Director, Clinical Compliance to lead the development and implementation of clinical quality initiatives. This leadership position ensures clinical trials are conducted in accordance with global regulatory standards, internal procedures, and best practices.

Key Responsibilities

• Provide strategic leadership for clinical compliance and training initiatives to support regulatory adherence and operational excellence.
• Act as the subject matter expert (SME) for Good Clinical Practice (GCP), compliance monitoring, audit readiness, and process improvements.
• Oversee the tracking and resolution of quality issues, including deviations, corrective actions, and quality events.
• Collaborate with cross-functional teams to conduct root cause analyses and develop effective CAPA strategies.
• Develop, implement, and manage comprehensive training programs to enhance compliance awareness and inspection readiness.
• Partner with various internal teams to ensure consistent and compliant execution of clinical development activities.
• Support audit and inspection activities, ensuring timely and effective responses to regulatory inquiries.

Qualifications

• In-depth knowledge of ICH/GCP guidelines and global clinical regulatory requirements.
• Bachelor’s degree in a science-related field; 15+ years of relevant industry experience in clinical operations and quality management.
• Proven leadership experience in developing and delivering training programs in a corporate environment.
• Strong project management, organizational, and communication skills.
• Experience with root cause analysis, CAPA management, and regulatory inspections.
• Ability to work effectively in a dynamic environment, managing multiple priorities.
• Onsite presence required; remote work not supported.