Associate Director, Clinical Operations
Listed on 2026-07-13
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Research/Development
Clinical Research, Regulatory Compliance Specialist
About Us
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.
PositionSummary
The Associate Director of Clinical Operations plays a pivotal role in leading clinical studies across all phases, ensuring efficient execution and compliance with regulatory standards. This senior‑level position requires collaboration with cross‑functional study teams, vendor management, and direct contributions to clinical development operations to drive study success in a dynamic, global environment.
Job Responsibilities- Clinical Study Leadership:
Lead and coordinate activities for assigned studies throughout all clinical trial phases—start‑up, conduct, and close‑out—ensuring alignment with corporate objectives and timelines. - Operational Strategy & Execution:
Work with leadership team to translate corporate strategies into operational plans within internal teams and external partners. Manage clinical study budgets, timelines, resource allocation, and vendor performance to ensure successful study delivery. - Risk Management:
Proactively identify and assess risks to study timelines, budget, and quality; develop and implement mitigation strategies in collaboration with stakeholders. - Vendor Oversight:
Manage relationships with clinical trial vendors, CROs, and sites to monitor progress, compliance with study protocols, GCP, and regulatory requirements. Oversee vendor deliverables and ensure quality standards. - Regulatory and Documentation Management:
Oversee the preparation, review, and finalization of all study‑related documents including protocols, informed consent forms, feasibility assessments, study plans, and electronic data capture (EDC) tools. Contribute to regulatory submissions and responses to Ethics Committees and Health Authorities. - Systems:
Collaborate with DM to review Case Report Forms (CRFs). Participate actively in EDC, IRT User Acceptance Testing (UAT), and other systems as required by protocol to ensure data integrity and system readiness. - Team Leadership & Development:
May include line management responsibilities involving recruitment, mentoring, career development, performance management, and talent retention for clinical operations staff. Foster a culture of accountability, continuous improvement, and collaborative problem‑solving. - Site & Investigator Engagement:
Assist in the selection and qualification of clinical investigators and sites. Conduct site monitoring oversight and lead site issue resolution, including escalation when necessary. - Safety & Compliance Oversight:
Work with cross‑functional Safety Review Committee meetings as required to support deliverables. Monitor data queries and ensure timely resolution. - Cross‑Functional
Collaboration:
Work closely with Preclinical, Biostatistics, Data Management, Clinical Supplies, Safety/PV, and Medical Affairs teams to ensure seamless study execution and IMP accountability, including sample management and study plan reviews. - Meetings & Representation:
Prepare and deliver presentations at investigator meetings and project team meetings. Act as a clinical operations representative at the project team level. - Process Improvement & SOP Management:
Update and maintain Standard Operating Procedures as…
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