Executive Director, Clinical Compliance & Readiness

Structure Therapeutics Inc.; 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

Winter shutdown holidays

Job summary

Structure Therapeutics Inc. is seeking an Executive Director, Clinical Compliance to lead regulatory compliance across early to late‑stage programs, with a primary focus on Phase 3 readiness, inspections, and sponsor oversight.

This role reports to the Senior VP, CDO and partners with QA, Regulatory, and Clinical Operations to establish scalable, risk‑based processes. The candidate will develop SOPs, strengthen CRO oversight, monitor TMF health, support CAPA management, and ensure documentation

Qualifications

• 15+ years in biotechnology/pharma or CRO with leadership roles.
• 7+ years in Director or Senior Director roles in Clinical Compliance or related.
• Extensive global experience across NA, EU, APAC and LATAM.
• Experience in Phase 3 regulatory submissions and inspections.
• Strong communication and leadership skills.

Responsibilities

• Provide strategic leadership for SOPs, TMF management, and vendor oversight.
• Ensure inspection readiness and sponsor oversight in Clinical Development Operations.
• Lead scalable, standardized processes and operating models across CDO.
• Develop and monitor quality frameworks, CAPA management, and KPIs.
• Identify and mitigate compliance risks to prevent findings or delays.
• Collaborate with QA, Regulatory Affairs, and Clinical Ops across programs.
• Report performance metrics to senior leadership and drive continuous improvement.
• Mentor and develop CDO leaders and teams.

Skills

Strategic Leadership

CRO Oversight

GCP Compliance

Regulatory Inspections

Data-driven Decision Making

Education

BA/BS with advanced degree preferred

Tools

TMF Systems

Job description

Structure Therapeutics Inc. is seeking an Executive Director, Clinical Compliance to lead regulatory compliance across early to late‑stage programs, with a primary focus on Phase 3 readiness, inspections, and sponsor oversight.

This role reports to the Senior VP, CDO and partners with QA, Regulatory, and Clinical Operations to establish scalable, risk‑based processes. The candidate will develop SOPs, strengthen CRO oversight, monitor TMF health, support CAPA management, and ensure documentation