Associate Director of Clinical Operations
Structure Therapeutics
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.
Essential Duties and responsibilities
· Provide oversight and leadership to cross functional Study Teams(s)
· Strong attention to detail and ability to prioritize tasks to meet critical deadlines
· Serve as the local operational lead for assigned clinical development programs
· Manage site and vendor relationships and ensure quality deliverables from CROs, CMOs, or other external partners.
· Manage overall study activities, including vendor selection, investigator recruitment and selection, study start-up, enrollment, data collection, study close out, and reports
· Identifies risks to study timelines and propose mitigations and implement solutions with team Contribute to the development of protocol, ICF, study plans, study reports, sections for Investigator's Brochures, and regulatory documents
· Ensure compliance with local regulatory, GCP, and company SOPs
· Collaborate with internal departments, including Clinical Science, Regulatory Affairs, Medical Writing Quality, and Clinical Development Operations
· Monitor timelines, budgets, and resources, proactively addressing risks and issues
· Contribute to the development of local strategies aligned with global program goals
· Represent Structure Therapeutics in meetings with sites and vendor partners in China as needed
· Coordinate with global and local stakeholders to ensure project milestones are met
· Represent Clinical Operations in internal project team meetings and making presentations as required
REQUIREMENTS
· BS and/or graduate degree in a technical discipline preferred with a minimum of 8 years of pharmaceutical and biotechnology industry experience running clinical trials
· Proven success in leading and coordinating global, cross-functional clinical operations teams
· Minimum 2 years clinical research experience in USA and at least 5 years experience running clinical trials based in China at a Sponsor company and/or CRO
· Early phase and/ or FIH clinical trial experience preferred
· Experience in selecting, managing, and overseeing sites, CROs, specialty labs and other service providers in China in global, multinational studies or programs.
· Strong interpersonal, problem-solving, organizational, and planning skills along with excellent verbal and written communication skills.
· Fluent in Mandarin and in English, both verbal and written.
· Experience working on global drug development programs with a strong understanding of China’s regulatory and clinical landscape
· Excellent interpersonal skills, strong written and verbal communication/presentation skills necessary to meet the needs of various audiences
· Strong leadership and project management skills, with the ability to work in a fast-paced environment
· Demonstrated ability to integrate and collaborate effectively into a remote team, cross-functional environment (US, China) with a positive attitude
· Strong sense of ethics, integrity, and honesty
· Demonstrated ability to manage complex projects across cross functional teams
· Travel up to 25%