Director, Clinical Operations, Cross Study Oversight

Structure Therapeutics•South San Francisco, CA

2d•$225,000 - $248,000•Onsite

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: The Director of Clinical Operations, Cross-Study Oversight provides strategic and operational leadership for global, late-phase clinical studies. This role serves as a senior operational escalation point and is responsible for ensuring consistency, quality, and operational excellence across study execution, vendor governance, site engagement, and external communications across mulitple late-phase studies. The Director drives delivery of complex, global, multi-regional trials by ensuring alignment with corporate strategy, regulatory requirements, and program timelines. This role partners cross-functionally to proactively identify risks, implement mitigation strategies, oversee budgets and accrual performance, and report study health and status to senior leadership.

Requirements

Bachelor’s degree or higher in a scientific or health-related discipline. Advanced degrees preferred.
Minimum of 12 years of clinical operations experience within a pharmaceutical, biotech, or CRO setting.
Experience leading global late-phase clinical trials, preferably in T2DM, obesity, or metabolic diseases.
Demonstrated experience serving in senior operational leadership roles with escalation accountability.
Proven expertise in budget oversight and financial forecasting for large global studies.
Strong knowledge of ICH-GCP guidelines and global regulatory requirements.
Experience managing global CRO partnerships and vendor governance models.

Nice To Haves

Analytical mindset with strong problem-solving skills and attention to detail.
Strong leadership qualities with excellent team management and interpersonal skills.
Exceptional organizational, planning, and prioritization abilities to manage multiple complex projects simultaneously.
Adaptable, self-motivated, and able to thrive in fast-paced, evolving environments.
Excellent verbal and written communication skills with the ability to influence stakeholders at all levels.
High ethical standards with a focus on compliance, integrity, and patient safety.
Collaborative mindset with experience integrating and working with remote and cross-cultural teams (e.g., US and APAC).

Responsibilities

Operational Leadership: Provide strategic oversight for concurrent, global late-phase clinical trials. Ensure operational alignment across multiple concurrent studies.
Escalation & Issue Resolution: Serve as primary operational escalation and mitigation point for study teams. Lead resolution of complex study-level and cross-functional issues including enrollment gaps, vendor performance challenges, protocol deviations, and regulatory risks.
Operational Consistency: Establish and enforce consistent processes and standards across studies, including vendor oversight frameworks, enrollment management strategies, site communications, and risk tracking methodologies.
Budget Oversight & Financial Governance: Review and approve study budgets and forecasts. Monitor financial performance across studies, identify budget risks, and lead mitigation planning in partnership with Finance and program leadership.
Enrollment and Retention Oversight: Oversee enrollment performance and forecasting across studies. Identify geographic and site-level trends and implement proactive mitigation strategies to ensure timely recruitment completion and implantation of retention strategies.
Risk Management: Proactively identify operational and program-level risks. Develop and implement structured mitigation plans and ensure transparent communication of risks to senior leadership.
Vendor & CRO Governance: Provide executive-level oversight of CROs and key vendors. Establish KPIs and performance metrics. Lead high-level vendor escalations and drive performance improvement initiatives.
Study Health Reporting: Provide regular reporting on study timelines, enrollment, financial health, quality metrics, and risk status to executive leadership and key stakeholders.
Regulatory & Compliance Oversight: Ensure studies are conducted in compliance with ICH-GCP, FDA, EMA, and global regulatory requirements. Drive inspection readiness and oversight of TMF quality and documentation standards.
Cross-Functional Collaboration: Partner closely with Clinical Development, Biostatistics, Data Management, Safety/PV, Regulatory, Clinical Supplies, and Medical Affairs to ensure seamless study execution.
Execution Support (as needed): Provide hands-on operational engagement during critical milestones, including investigator meeting preparation, vendor bid reviews, enrollment and retention activities, budget re-forecasting, and inspection preparation.
Team Leadership & Development: Lead and mentor Clinical Operations staff. Contribute to capacity planning, organizational development, and succession planning initiatives.
Process Improvement & SOP Management: Drive continuous improvement initiatives and development of scalable operational frameworks to support expanding late-stage programs.