Associate Director, Trial Master File

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.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. 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.Job ResponsibilitiesProvide strategic leadership and sponsor oversight for the electronic Trial Master File (eTMF) across all clinical studiesEnsure TMF completeness, accuracy, and timeliness throughout the study lifecycle to support continuous inspection readinessLead the development, implementation, and maintenance of TMF governance, including SOPs, work instructions, and guidanceEstablish and monitor TMF performance metrics and KPIs, using data to identify trends, risks, and improvement opportunitiesOversee CRO and vendor TMF activities, ensuring delegated responsibilities are executed in compliance with contractual and regulatory expectationsServe as the TMF subject matter expert for audits, health authority inspections, and regulatory interactionsDrive risk‑based TMF oversight, issue management, and CAPA development related to TMF quality or compliance gapsPartner cross‑functionally with Clinical Operations, Quality, Regulatory Affairs, and IT to ensure alignment and effective oversightLead or support TMF system implementation, optimization, and integration activities, including validation and change managementDevelop and deliver TMF training and guidance for internal teams and external partnersEnsure clear documentation of sponsor oversight and decision‑making in accordance with ICH GCP and regulatory expectationsSupport scalability and operational maturity of TMF processes as the clinical portfolio growsMentor and guide TMF team members or contractors, as applicableQualifications: Bachelor’s degree or higher in a scientific or health-related discipline. Advanced degrees preferred.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 complianceIn‑depth knowledge of ICH GCP (E6 R2/R3), TMF Reference Model, and global regulatory expectationsProven experience operating within a CRO‑heavy or outsourced clinical trial model, including sponsor oversight and vendor managementStrong experience with eTMF systems (e.g., Veeva Vault, Trial Interactive, Wingspan) and TMF metrics/KPIsTrack record of supporting audits and health authority inspections as a TMF subject matter expertExperience developing and implementing SOPs, work instructions, and governance frameworksAbility to assess TMF risk, manage issues and CAPAs, and drive continuous improvement initiativesStrong cross‑functional collaboration skills, with the ability to influence without direct authorityExcellent written and verbal communication skills, including executive‑level presentation and storytellingDemonstrated leadership, organizational, and change‑management capabilities in a growing biotech environmentDesired Skills & Competencies:Deep expertise in eTMF management, governance, and lifecycle oversightStrong understanding of ICH GCP (E6 R2/R3) and health authority expectations related to TMFAbility to interpret and apply the TMF Reference Model pragmaticallyProven inspection‑readiness mindset with the ability to defend TMF strategy and decisionsDemonstrated ability to provide effective sponsor oversight in outsourced/CRO‑led modelsStrong risk identification, assessment, and mitigation skills related to TMF quality and complianceExperience managing TMF issues, deviations, and CAPAsAbility to distinguish true TMF risk vs. noise using data and judgmentAbility to lead through influence across cross‑functional and vendor teamsConfident decision‑making balanced with appropriate escalationCapability to mentor, guide, and set expectations for TMF staff and contractorsStrong stakeholder management skills, including communication with senior leadershipExcellent written and verbal communication skills, including clear, concise executive‑level messagingAbility to translate detailed TMF data into meaningful insights and narrativesSkilled at presenting complex issues with clarity during audits and inspectionsProven experience developing and implementing SOPs, work instructions, and governance modelsStrong change‑management skills in evolving or scaling organizationsAbility to balance structure with agility in a growing biotech environmentHighly collaborative, with the ability to work effectively across Clinical Operations, Quality, Regulatory, and ITDetail‑oriented with strong organizational and prioritization skillsComfortable operating in fast‑paced, ambiguous environments while maintaining complianceTravel Required: Up to 20%Structure Therapeutics Inc. is an Equal-Opportunity Employer.Structure Therapeutics is committed to fair and equitable compensation practices, and we strive to provide employees with total compensation packages that are market competitive. For this role, the anticipated base pay range is $163,000 - $185,000.The exact base pay offered for this role will depend on various factors, including but not limited to the candidate’s geography, qualifications, skills, and experience.At Structure, base pay is only one part of your total compensation package. 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.Notice to Recruiters/Staffing AgenciesRecruiters and staffing agencies should not contact Structure Therapeutics through this page. All recruitment vendors (search firms, recruitment agencies, and staffing companies) are prohibited from contacting our hiring manager(s), executive team members, or employees.We require that all recruiters and staffing agencies have a fully executed, formal written agreement on file.Structure Therapeutics’ receipt or acceptance of an unsolicited resume submitted by a vendor organization to this website or employee does not constitute an actual or implied contract between Structure Therapeutics and such organization and will be considered unsolicited and Structure Therapeutics will not be responsible for related fees.Fraud AlertTo all candidates: your personal information and online safety are a top priority for us. At Structure Therapeutics, direct candidates to apply through our official career page at BambooHR.Recruiters will always contact you using the domain of Structuretx.com. 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