Senior Director, Clinical Compliance & Inspection Readiness

Structure Therapeutics; South San Francisco (CA); On-site; USD 283,000 - 325,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401k match

Unlimited PTO

Paid holidays

Job summary

Structure Therapeutics seeks an Executive Director, Clinical Compliance to lead clinical compliance and operational readiness across early and late-phase programs, with a focus on Phase 3 readiness and inspections. You will establish scalable, risk-based processes, strengthen CRO/vendor oversight, and drive continual improvement.

The role collaborates with Clinical Operations, QA, Regulatory Affairs, Data Management, Biostatistics, and other functions, reporting to the SVP, CDO.

Qualifications

• 15+ years in biotech/pharma with leadership roles
• Experience building and leading Clinical Compliance or Operational Excellence teams
• Global trials experience across NA, Europe, Asia-Pacific, and LATAM
• Phase 3 regulatory submissions and US/ex-US inspections
• Strong strategic planning and people leadership abilities

Responsibilities

• Provide strategic leadership for SOP development, TMF management, process improvement, and vendor oversight.
• Partner with Clinical Quality Assurance to ensure inspection readiness and regulatory submissions.
• Lead development and improvement of scalable processes, systems, and operating models across CDO.
• Establish sponsor and vendor oversight, eTMF governance, SOPs and work instructions, quality monitoring.
• Develop and report clinical KPIs at Quality Management Reviews and senior governance forums.

Skills

Leadership

Strategic thinking

Regulatory knowledge

Cross-functional collaboration

Communication

Education

BA/BS with advanced degree preferred

Job description

Structure Therapeutics seeks an Executive Director, Clinical Compliance to lead clinical compliance and operational readiness across early and late-phase programs, with a focus on Phase 3 readiness and inspections. You will establish scalable, risk-based processes, strengthen CRO/vendor oversight, and drive continual improvement.

The role collaborates with Clinical Operations, QA, Regulatory Affairs, Data Management, Biostatistics, and other functions, reporting to the SVP, CDO.