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About the Role

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.

Responsibilities

• 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.
• 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.
• Proactively identify and assess risks to study timelines, budget, and quality; develop and implement mitigation strategies in collaboration with stakeholders.
• 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.
• 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.
• 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.
• 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.
• Assist in the selection and qualification of clinical investigators and sites.
• Conduct site monitoring oversight and lead site issue resolution, including escalation when necessary.
• Work with Cross functional Safety Review Committee meetings as required to support deliverables.
• Monitor data queries and ensure timely resolution.
• 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.
• Prepare and deliver presentations at investigator meetings and project team meetings.
• Act as a clinical operations representative at the project team level.
• Update and maintain Standard Operating Procedures as assigned.
• Drive continuous improvement initiatives within clinical operations.

Requirements

• Bachelor’s degree or higher in a scientific or health-related discipline. Advanced degrees preferred.
• Minimum of 8 years of clinical operations experience within a pharmaceutical, biotech, or CRO setting.
• At least 6 years in roles such as Clinical Research Associate (CRA), Senior CRA, or Clinical Trial Manager (CTM).
• Proven experience managing Phase I to III clinical trials and leading start-up activities.
• Strong knowledge of ICH-GCP guidelines, FDA, EMA, and other applicable global regulatory requirements.
• Experience leading global, multi-regional clinical trials, with a preference for Asia-Pacific expertise.
• Demonstrated ability to lead cross-functional teams and manage complex vendor relationships.

Skills

• Analytical mindset
• Strong problem-solving skills
• Attention to detail
• Strong leadership qualities
• Excellent team management skills
• Excellent interpersonal skills
• Exceptional organizational abilities
• Exceptional planning abilities
• Exceptional prioritization abilities
• Adaptable
• Self-motivated
• Able to thrive in fast-paced, evolving environments
• Excellent verbal communication skills
• Excellent written communication skills
• Ability to influence stakeholders at all levels
• High ethical standards
• Focus on compliance
• Focus on integrity
• Focus on patient safety
• Collaborative mindset
• Experience integrating and working with remote and cross-cultural teams (e.g., US and APAC)

Location

• California
• Shanghai

Work Type

• Full-time

Experience Level

• Associate Director
• Senior-level

Education Level

• Bachelor's degree or higher in a scientific or health-related discipline
• Advanced degrees preferred

Salary/Compensations

• $186,000-$220,000

Benefits

• Annual performance incentive bonus
• New hire equity
• Ongoing performance-based equity
• Medical insurance
• Dental insurance
• Vision insurance
• 401k match
• Unlimited PTO
• Paid holidays
• Winter shutdown

About the Company

• 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.

Equal Opportunity

• Structure Therapeutics Inc. is an Equal-Opportunity Employer.