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.
Job 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.
Education
BA/BS required, with advance degree preferred, in a technical discipline
Experience
- 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
Core competencies and 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
Structure Therapeutics is committed to fair and equitable compensation practices, and we strive to provide employees with total compensation packages that are market competitive. For this role, the anticipated base pay range is $283,000-$325,000. The exact base pay offered for this role will depend on various factors, including but not limited to the candidate's geography, qualifications, skills, and experience.
At Structure, base pay is only one part of your total compensation package. The successful candidate will be eligible for an annual performance incentive bonus, new hire equity, and ongoing performance-based equity. Structure Therapeutics also offers various benefits offerings, including, but not limited to, medical, dental, and vision insurance, 401k match, unlimited PTO, and a number of paid holidays including winter shutdown.
Notice to Recruiters/Staffing Agencies
Recruiters and staffing agencies should not contact Structure Therapeutics through this page. All recruitment vendors (search firms, recruitment agencies, and staffing companies) are prohibited from contacting our hiring manager(s), executive team members, or employees.
We require that all recruiters and staffing agencies have a fully executed, formal written agreement on file.
Structure Therapeutics' receipt or acceptance of an unsolicited resume submitted by a vendor organization to this website or employee does not constitute an actual or implied contract between Structure Therapeutics and such organization and will be considered unsolicited and Structure Therapeutics will not be responsible for related fees.
Fraud Alert
To all candidates: your personal information and online safety are a top priority for us. At Structure Therapeutics, direct candidates to apply through our official career page at BambooHR.
Recruiters will always contact you using the domain of Structuretx.com. We will never request payments, ask for financial account information or sensitive information like social security numbers. If you are unsure if a message is from Structure Therapeutics, please email human resources.
