Associate Director, Trial Master File

Structure Therapeutics•South San Francisco, CA

8d•Onsite

About The Position

The Associate Director, Trial Master File at Structure Therapeutics will report to a Director, Vendor Oversight and Process Improvement. 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.

Requirements

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

Nice To Haves

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

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