Sr. Director, Clinical Operations

Structure Therapeutics•South San Francisco, CA

2d•Hybrid

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. We are seeking a Senior Director, Clinical Operations, who acts as both a strategic leader and a tactical driver. This role is directly responsible for the clinical operations delivery of global clinical trials, requiring proven global clinical operations leadership. The successful candidate must be a leader who can pivot seamlessly from high-level strategic planning to the daily tactical details of operational execution. The ideal candidate thrives in a fast-paced biotech environment, possessing a proven track record of building high-performing teams while remaining deeply involved in the clinical development lifecycle and vendor oversight. This position follows a hybrid work model, requiring three days of onsite presence per week at our South San Francisco office.

Requirements

BS or advanced degree in life sciences or related field.
Prior Phase 3 global operational leadership is required, and cardio-metabolic experience is highly preferred.
Minimum 12+ years of progressive experience in clinical research, with at least 5 years in senior leadership roles.

Nice To Haves

cardio-metabolic experience is highly preferred

Responsibilities

Develop and drive clinical trial strategies aligned with corporate goals, while maintaining direct oversight of tactical delivery to ensure timelines and milestones are met.
Drive late-stage clinical programs from planning through completion, providing the direct oversight necessary to ensure cost-effective, high-quality delivery
Serve as the operational lead for clinical development programs, working closely with regulatory, medical, biostatistics, and other departments.
Demonstrated success in managing global clinical trials across multiple therapeutic areas.
Lead, mentor, and grow a team of clinical trial professionals including Clinical Project Managers, Clinical Research Associates, and other key stakeholders.
Promote a culture of accountability, transparency, continuous improvement, and high performance.
Oversee study start-up, site identification, patient recruitment, data collection, and monitoring processes.
Ensure compliance with SOPs, ICH/GCP, and relevant regulatory requirements across all clinical activities.
Develop, manage, and track clinical trial budgets, timelines, and resource allocation.
Demonstrated understanding of pharmaceutical regulatory requirements and impact on development of clinical trials.
Select, contract, and manage CROs, central labs, and other third-party vendors.
Establish and maintain productive relationships with key external partners to ensure deliverables are met.
Partner closely with Clinical Development, Regulatory Affairs, Quality Assurance, and Data Management teams.
Represent clinical operations in leadership meetings and provide regular updates to executive stakeholders.
Excellent communication and interpersonal skills with the ability to influence stakeholders at all levels.