structuretx

structuretx

Associate Director, Trial Master File

South San Francisco, California · Director

Sponsorship not specified$163k-$200kDetected 20 days ago
GCPComplianceStakeholder ManagementProcess ImprovementVendor ManagementClinical TrialsClinical ResearchFDA RegulatoryResearchLeadershipCommunicationCollaborationPublic SpeakingRegulatory Affairs

About the role

  • The Associate Director provides leadership over TMF strategy, vendor oversight, inspection preparedness, and cross‑functional alignment, ensuring TMF completeness, quality, and timeliness throughout the study lifecycle.
  • Provide strategic leadership and sponsor oversight for the electronic Trial Master File (eTMF) across all clinical studies
  • Establish and monitor TMF performance metrics and KPIs, using data to identify trends, risks, and improvement opportunities

Responsibilities

  • This role ensures that TMF processes, systems, and controls support inspection readiness, regulatory compliance, and efficient clinical trial execution.
  • Ensure TMF completeness, accuracy, and timeliness throughout the study lifecycle to support continuous inspection readiness
  • Drive risk‑based TMF oversight, issue management, and CAPA development related to TMF quality or compliance gaps
  • Lead or support TMF system implementation, optimization, and integration activities, including validation and change management
  • Develop and deliver TMF training and guidance for internal teams and external partners
  • Support scalability and operational maturity of TMF processes as the clinical portfolio grows

Requirements

  • Minimum of 8-10 years of clinical research experience within a pharmaceutical, biotech, or CRO setting.
  • Demonstrated expertise in eTMF governance, inspection readiness, and regulatory compliance
  • In‑depth knowledge of ICH GCP (E6 R2/R3), TMF Reference Model, and global regulatory expectations
  • Proven experience operating within a CRO‑heavy or outsourced clinical trial model, including sponsor oversight and vendor management
  • Strong experience with eTMF systems (e.g., Veeva Vault, Trial Interactive, Wingspan) and TMF metrics/KPIs
  • Strong cross‑functional collaboration skills, with the ability to influence without direct authority
  • Bachelor's degree or higher in a scientific or health-related discipline.
  • Track record of supporting audits and health authority inspections as a TMF subject matter expert
  • Experience developing and implementing SOPs, work instructions, and governance frameworks
  • Ability to assess TMF risk, manage issues and CAPAs, and drive continuous improvement initiatives
  • Excellent written and verbal communication skills, including executive‑level presentation and storytelling

Nice to have

  • Advanced degrees preferred.

Skills

  • Deep expertise in eTMF management, governance, and lifecycle oversight
  • Strong understanding of ICH GCP (E6 R2/R3) and health authority expectations related to TMF
  • Ability to interpret and apply the TMF Reference Model pragmatically
  • Proven inspection‑readiness mindset with the ability to defend TMF strategy and decisions
  • Demonstrated ability to provide effective sponsor oversight in outsourced/CRO‑led models
  • Strong risk identification, assessment, and mitigation skills related to TMF quality and compliance
  • Experience managing TMF issues, deviations, and CAPAs
  • Ability to distinguish true TMF risk vs. noise using data and judgment
  • Confident decision‑making balanced with appropriate escalation
  • Capability to mentor, guide, and set expectations for TMF staff and contractors
  • Strong stakeholder management skills, including communication with senior leadership
  • Excellent written and verbal communication skills, including clear, concise executive‑level messaging

Compensation

  • For this role, the anticipated base pay range is $163,000 - $200,000.

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.
  • Serve as the TMF subject matter expert for audits, health authority inspections, and regulatory interactions

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, Trial Master File at Structure Therapeutics will report to a Director, Vendor Oversight and Process Improvement and The Associate Director, Trial Master File (TMF) is responsible for the strategic oversight, governance, and continuous improvement of the electronic Trial Master File across the clinical trial portfolio. This role ensures that TMF processes, systems, and controls support inspection readiness, regulatory compliance, and efficient clinical trial execution.
  • 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.
  • The Associate Director, Trial Master File at Structure Therapeutics will report to a Director, Vendor Oversight and Process Improvement and The Associate Director, Trial Master File (TMF) is responsible for the strategic oversight, governance, and continuous improvement of the electronic Trial Master File across the clinical trial portfolio.
  • The role serves as a key partner to Clinical Operations, Quality, Regulatory Affairs, and external vendors, maintaining sponsor accountability for TMF integrity while enabling scalable operations as the organization grows.

Visa & Work Authorization

  • The role serves as a key partner to Clinical Operations, Quality, Regulatory Affairs, and external vendors, maintaining sponsor accountability for TMF integrity while enabling scalable operations as the organization grows.
  • Provide strategic leadership and sponsor oversight for the electronic Trial Master File (eTMF) across all clinical studies
  • Ensure clear documentation of sponsor oversight and decision‑making in accordance with ICH GCP and regulatory expectations
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