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About the Role
Structure Therapeutics is seeking a talented, strategic, and highly motivated Executive Director, Clinical Compliance to lead clinical compliance and operational readiness across the company’s early and late-phase clinical development programs. This individual will establish and maintain scalable, risk-based processes that support consistent execution, documented sponsor oversight, and continuous inspection readiness, with a primary focus on Phase 3 readiness, inspection planning, and regulatory inspections. The Executive Director, Clinical Compliance will report to the Senior Vice President, Clinical Development Operations (CDO).
Responsibilities
- Provide strategic leadership for the CDO functions responsible for SOP development, TMF management, process improvement, and vendor oversight.
- Partner closely with Clinical Quality Assurance to ensure Clinical Development Operations is inspection-ready and prepared for regulatory submissions.
- 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.
- 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.
Requirements
- 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
Skills
- 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
Location
- California
- Shanghai
Work Type
- Full-time
Experience Level
- 15+ years of progressive experience
- at least seven years in Director or Senior Director level roles
Education Level
- BA/BS required
- advance degree preferred
Salary/Compensations
- $283,000-$325,000
Benefits
- Annual performance incentive bonus
- New hire equity
- Ongoing performance-based equity
- Medical insurance
- Dental insurance
- Vision insurance
- 401k match
- Unlimited PTO
- Paid holidays including winter shutdown
About the Company
- 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.
Equal Opportunity
- Structure Therapeutics Inc. is an Equal-Opportunity Employer.