Associate Clinical Operations Compliance Director

Location: Alameda, California, United States; onsite office environment

Salary: $168,500–$238,500 annually, adjusted by geographic market

Company

Clinical research and compliance activities are supported across Clinical Operations, Quality Assurance, Clinical Development, Data Management, and R&D functions.

What you will do

• Support risk and issue management for compliant clinical study execution.
• Develop functional risk-management strategies and annual plans supporting inspection readiness.
• Coordinate CAPA ownership, follow-up, completion tracking, and escalation of overdue items.
• Act as a liaison between Clinical Operations, Quality Assurance, and other R&D functions.
• Contribute to GCP and process training, quality analytics, inspection readiness, mock inspections, and health authority responses.
• Oversee monitoring quality, CRO performance, risk-based monitoring signals, and escalation of site and data issues.

Requirements

• Bachelor’s degree with at least 11 years of related experience, master’s degree with at least 9 years, doctoral degree with at least 5 years, or an equivalent combination.
• Experience in the biotech or pharmaceutical industry.
• Strong knowledge of biopharmaceutical regulations, standards, and best practices, including ICH GCP.
• Understanding of the relevant scientific, legal, and regulatory environment.
• Strong analytical, strategic thinking, problem-solving, organizational, communication, presentation, and change-management skills.
• Advanced knowledge of Microsoft Excel, Word, PowerPoint, and Outlook.

Culture & Benefits

• Modern open-plan office designed to support collaboration and creativity.
• Close teamwork and knowledge sharing in a supportive environment.
• Dual monitors and ergonomic chairs provided.
• 401(k) plan, medical, dental, vision, life, disability, and flexible spending benefits.
• Annual bonus eligibility, stock purchase opportunities, long-term incentives, paid vacation, holidays, and sick days.