Executive Director, Clinical Compliance

Structure Therapeutics develops life‑changing medicines for patients using advanced structure‑based and computational drug discovery technology. The company’s platform combines the latest advancements in visualization of molecular interactions, computational chemistry, and data integration to design orally available, superior small molecule medicines that overcome current limitations of biologic and peptide drugs. We are advancing a clinical‑stage pipeline of differentiated treatments focused on chronic diseases with high unmet need, including cardiovascular, metabolic, and pulmonary conditions.

Structure Therapeutics is led by an experienced group of international drug innovators and financed by top‑tier global life sciences investors. The company completed an initial public offering (IPO) in February 2023. With offices in California and Shanghai, Structure Therapeutics has the benefit of being at the center of life science innovation in both the US and China and capitalizing on the strengths of each geographic location.

Structure is seeking a talented, strategic, and highly motivated Executive Director, Clinical Compliance to lead clinical compliance and, in partnership with Clinical Quality Assurance, operational readiness across the company’s early and late‑phase clinical development programs. With a primary focus on Phase 3 readiness, inspection planning, and regulatory inspections, this individual will establish and maintain scalable, risk‑based processes that support consistent execution, documented sponsor oversight, and continuous inspection readiness.

The Executive Director, Clinical Compliance will report to the Senior Vice President, Clinical Development Operations (CDO).

The Executive Director will partner closely with Clinical Operations, Clinical Outsourcing, TMF, Quality, Regulatory Affairs, Clinical Development, Data Management, Biostatistics, Clinical Supplies, and other key functions. Responsibilities will include leading clinical compliance strategy, strengthening CRO and vendor oversight, CDO SOP development, monitoring TMF health and process adherence, supporting CAPA management, and ensuring that operational documentation is complete, traceable, and inspection‑ready.

The role will also apply fit‑for‑purpose standards and processes to early‑phase programs to establish a strong foundation for future late‑stage development and regulatory submissions. This position requires an experienced leader who can influence across functions, identify and proactively address compliance risks, and provide senior leadership with clear visibility into readiness, emerging risks, and required actions.

• Provide strategic leadership for the CDO functions responsible for SOP development, TMF management, process improvement, and vendor oversight, including organizational design, recruitment, performance management, and professional development.
• Partner closely with Clinical Quality Assurance to ensure Clinical Development Operations is inspection‑ready and prepared for regulatory submissions. Key areas of focus include Trial Master File quality, sponsor oversight documentation, GCP procedures, clinical trial issue management, training compliance, and consistent adherence to established processes.
• Lead the development, implementation, and continuous improvement of scalable, standardized processes, systems, and operating models across CDO.
• Establish and maintain a proactive framework encompassing sponsor and vendor oversight, eTMF governance, SOPs and Work Instructions, quality monitoring, change management, and inspection readiness.
• Drive consistent adoption and effective implementation of operational processes, systems, and quality standards across…