Associate Director, Trial Master File

About Us:

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 Responsibilities

• Provide strategic leadership and sponsor oversight for the electronic Trial Master File (eTMF) across all clinical studies
• Ensure TMF completeness, accuracy, and timeliness throughout the study lifecycle to support continuous inspection readiness
• Lead the development, implementation, and maintenance of TMF governance, including SOPs, work instructions, and guidance
• Establish and monitor TMF performance metrics and KPIs, using data to identify trends, risks, and improvement opportunities
• Oversee CRO and vendor TMF activities, ensuring delegated responsibilities are executed in compliance with contractual and regulatory expectations
• Serve as the TMF subject matter expert for audits, health authority inspections, and regulatory interactions
• Drive risk‑based TMF oversight, issue management, and CAPA development related to TMF quality or compliance gaps
• Partner cross‑functionally with Clinical Operations, Quality, Regulatory Affairs, and IT to ensure alignment and effective oversight
• 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
• Ensure clear documentation of sponsor oversight and decision‑making in accordance with ICH GCP and regulatory expectations
• Support scalability and operational maturity of TMF processes as the clinical portfolio grows
• Mentor and guide TMF team members or contractors, as applicable

Qualifications: 

• 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 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

• 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
• Strong cross‑functional collaboration skills, with the ability to influence without direct authority
• Excellent written and verbal communication skills, including executive‑level presentation and storytelling
• Demonstrated leadership, organizational, and change‑management capabilities in a growing biotech environment

Desired Skills & Competencies:

• 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
• Ability to lead through influence across cross‑functional and vendor teams
• 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
• Ability to translate detailed TMF data into meaningful insights and narratives
• Skilled at presenting complex issues with clarity during audits and inspections
• Proven experience developing and implementing SOPs, work instructions, and governance models
• Strong change‑management skills in evolving or scaling organizations
• Ability to balance structure with agility in a growing biotech environment
• Highly collaborative, with the ability to work effectively across Clinical Operations, Quality, Regulatory, and IT
• Detail‑oriented with strong organizational and prioritization skills
• Comfortable operating in fast‑paced, ambiguous environments while maintaining compliance

Travel 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.

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