Sr. Director of Clinical Operations, APAC Region at Structure Therapeutics

Pudong, Shanghai, China -

Full Time

Start Date

Immediate

Expiry Date

21 Dec, 25

Salary

0.0

Posted On

22 Sep, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Operations, Regulatory Compliance, Team Leadership, Vendor Management, Clinical Trials, Budget Management, Patient Recruitment, Cross-Functional Collaboration, Strategic Planning, Data Privacy, Communication Skills, Cultural Agility, Project Management, Clinical Development, Operational Excellence, Stakeholder Engagement

Industry

Biotechnology Research

Description

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 has completed an initial public offering (IPO) in February of 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 We are seeking a highly experienced Sr. Director of Clinical Operations, APAC Region to lead the execution and oversight of clinical development programs across the Asia-Pacific region, with a primary focus on China. This individual will be based in Shanghai and will serve as the senior operational leader responsible for ensuring high-quality, timely, and compliant delivery of clinical trials across multiple therapeutic areas. The ideal candidate brings extensive experience navigating the Chinese regulatory and operational environment, strong leadership in building and scaling teams but also hands-on and nimble in working with vendor partners, and a proven track record of successfully executing on global, and regional development clinical trials. Essential Duties and responsibilities Strategic Leadership Lead the planning, execution, and delivery of clinical trials in APAC, with primary accountability for China. Partner with global leadership and global clinical development operations to shape the APAC clinical trials execution strategy, ensuring regional needs and opportunities are integrated into global development plans. Serve as the senior operational point of contact for APAC trials, providing strategic input into study design, feasibility, and country selection. Operational Excellence Oversee trial start-up, conduct, and close-out, ensuring compliance with ICH-GCP, NMPA regulations, and SOPs. Responsible for developing RFPs, local operation vendor selection, , as well as budget negotiation when needed Manage clinical trial budgets, contracts, and vendor oversight, ensuring cost-effective delivery. Drive site engagement and patient recruitment and retention strategies tailored for the China/APAC landscape. Coordinate clinical site audit activities and inspection readiness in partnership with QA Lead and ensure compliance with HGRAC requirements by overseeing study planning, regulatory submissions, site training, biosample/data management, vendor oversight, and documentation throughout the clinical trial lifecycle. Leadership & Team Development Build, lead, and mentor a high-performing Clinical Operations team. Foster a culture of collaboration, accountability, and continuous improvement across clinical operations. Provide coaching and professional development opportunities for clinical operations staff. Cross-Functional Collaboration Work closely with Regulatory, Clinical Development, Clinical Supplies Planning/Logistics, CMC, Quality, Pharmacovigilance, and other global functions to ensure seamless program execution. Represent APAC Clinical Operations on global project teams and governance committees. Partner with external stakeholders including CROs, academic institutions, investigators, and KOLs in the region. Qualifications & Experience Advanced degree in life sciences, medicine, pharmacy, or related field preferred 15+ years of clinical operations experience, with at least 8–10 years in China/APAC leadership roles Proven success in delivering Phase I–III clinical trials in China under NMPA oversight, including IND submissions, EC engagement, and HGRAC requirement. Deep knowledge of Chinese regulatory and operational environment, including PIPL/DSL data privacy, import/export drug regulations, and clinical site landscape Strong vendor management experience (CROs, labs, depots, technology providers) Demonstrated ability to lead cross-functional and multicultural teams across APAC Leads by example, role model for APAC Clinical Operations team, demonstrates a firm commitment to company values and culture Effective, proactive, and open communication to achieve transparency and clarity of clinical trial goals with team members, executive management, key stakeholders and broader organization Comfortable multi-tasking in a fast-paced global company environment and able to adjust based upon changing priorities and various time zones Excellent communication skills in both Mandarin and English (written and spoken) Proven ability to influence, negotiate, and build relationships with global stakeholders and regulatory authorities Experience in metabolic diseases (Obesity, T2DM, MASH), infectious disease, or other chronic high-priority therapeutic areas preferred Key Attributes Strategic thinker with the ability to anticipate challenges in complex regulatory/operational landscapes Hands-on, execution-focused leader comfortable working in both start-up and global biopharma environments Strong interpersonal skills and cultural agility to operate across diverse APAC geographies Entrepreneurial mindset, adaptable, and resilient in fast-changing environments

Responsibilities

Lead the execution and oversight of clinical development programs across the Asia-Pacific region, focusing primarily on China. Ensure high-quality, timely, and compliant delivery of clinical trials across multiple therapeutic areas.