structuretx

structuretx

Associate Director, Clinical Operations

South San Francisco, California · Director

Sponsorship not specified$186k-$220kDetected 13 days ago
GCPProcess ImprovementVendor ManagementPerformance ManagementClinical TrialsClinical ResearchFDA RegulatoryResearchAnimal StudiesLeadershipCommunicationCollaborationProblem SolvingMentoringPublic SpeakingAdaptabilityBiostatistics

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.
  • Oversee vendor deliverables and ensure quality standards.
  • Contribute to regulatory submissions and responses to Ethics Committees and Health Authorities.

Responsibilities

  • 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.
  • 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.
  • Prepare and deliver presentations at investigator meetings and project team meetings.
  • Update and maintain Standard Operating Procedures as assigned.
  • Drive continuous improvement initiatives within clinical operations.
  • 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.
  • 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.

Requirements

  • 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.
  • Bachelor's degree or higher in a scientific or health-related discipline. Advanced degrees preferred.
  • Demonstrated ability to lead cross-functional teams and manage complex vendor relationships.
  • Desired Skills & Competencies:
  • Strong leadership qualities with excellent team management and interpersonal skills.
  • Exceptional organizational, planning, and prioritization abilities to manage multiple complex projects simultaneously.

Nice to have

  • Advanced degrees preferred.

Skills

  • Analytical mindset with strong problem-solving skills and attention to detail.
  • Adaptable, self-motivated, and able to thrive in fast-paced, evolving environments.
  • Excellent verbal and written communication skills with the ability to influence stakeholders at all levels.
  • High ethical standards with a focus on compliance, integrity, and patient safety.
  • Collaborative mindset with experience integrating and working with remote and cross-cultural teams (e.g., US and APAC).

Compensation

  • For this role, the anticipated base pay range is $186,000-$220,000.

Benefits

  • The successful candidate will be eligible for an annual performance incentive bonus, new hire equity, and ongoing performance-based equity.
  • Structure Therapeutics also offers various benefits offerings, including, but not limited to, medical, dental, and vision insurance, 401k match, unlimited PTO, and a number of paid holidays including winter shutdown.

Company info

  • 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.
  • Position Summary:
  • 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.
  • 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.
  • 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.
Apply directly at structuretx →Create a free account for alerts like thisView structuretx immigration profile

This listing is sourced directly from structuretx's careers page and normalized into a canonical job model.