Executive Director, Clinical Compliance

Structure Therapeutics•South San Francisco, CA

About The Position

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. Position Summary: 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.

Requirements

BA/BS required, with advance degree preferred, in a technical discipline
15+ years of progressive experience, including at least seven years in Director or Senior Director level roles in the biotechnology, pharmaceutical, or CRO industry spanning Clinical Compliance, Clinical Quality, Clinical Development Operations, or Operational Excellence
Demonstrated experience building, developing, and leading a high-performing Clinical Compliance or Operational Excellence team
Extensive operational and compliance experience across early-phase, Phase 2, and global Phase 3 clinical trials conducted in North America, Europe, Asia-Pacific, and Latin America
Demonstrated experience in Phase 3 regulatory submission and US and ex-US inspections
In-depth knowledge of global regulatory requirements and Good Clinical Practice (GCP) standards, including ICH guidelines and FDA and EMA requirements. Familiarity with NMPA requirements is preferred.
Proven experience establishing clinical performance indicators and using data-driven, innovative, and agile approaches to design, implement, and continuously improve processes.
Exceptional strategic planning, organizational, and people-leadership capabilities, with a demonstrated ability to lead teams effectively in a dynamic, fast-paced environment with multiple competing priorities
Strong executive communication and influencing skills, including the ability to translate complex compliance and operational information into clear, data-driven insights and recommendations for senior leadership
Solutions-oriented and results-driven, with sound judgment, a strong sense of ownership, and a willingness to take a hands-on approach when needed to resolve complex issues and deliver organizational priorities
Risk based management skill and mindset
Fosters Teamwork
Provides and Solicits Honest and Actionable Feedback
Self-Awareness
Acts Inclusively
Demonstrates Initiative
Entrepreneurial Mindset
Continuous Learning
Embraces Change
Results-Oriented
Communicates with Clarity
Action-oriented with excellent problem-solving skills
Strong sense of integrity

Responsibilities

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 clinical programs and trials.
Proactively identify, assess, and resolve operational and compliance risks before they result in inspection findings, regulatory submission delays, quality issues, or costly remediation.
Partner with Clinical Quality Assurance to monitor compliance with GCP requirements, company procedures, and training expectations and to assess emerging compliance risks across Clinical Development Operations.
Develop, implement, and report meaningful clinical performance and KPIs at quarterly Quality Management Reviews and other senior leadership or governance forums.
Use data-driven insights to identify trends, inform decisions, and drive continuous improvement.
Champion operational excellence throughout Clinical Development Operations by promoting accountability, innovation, cross-functional collaboration, and a culture of continuous improvement.
Build and lead high-performing teams capable of strengthening clinical infrastructure, optimizing systems and processes, and supporting the organization’s evolving development portfolio.
Mentor and coach CDO leaders and team members, strengthening functional capabilities and empowering teams to deliver high-quality, compliant, and efficient clinical programs.
Exhibit our values of Passion, Teamwork, Integrity, Innovation, and Patient Focus to help get medicines accessible around the world.