Why This Job is Featured on The SaaS Jobs
This role stands out as a build-and-standardise mandate inside a regulated, systems-heavy operating environment. Although the employer is not a SaaS company, the work maps closely to SaaS-style platform ownership: selecting and governing an enterprise system, defining data and document standards, and running an operational transition from an outsourced model to an internal capability. The emphasis on electronic TMF operations and inspection readiness mirrors the kind of auditability and process discipline seen in mature SaaS organisations serving regulated customers.
From a SaaS career perspective, the transferable value sits in operating at the intersection of process, tooling, and cross-functional execution. Establishing governance, KPIs, and repeatable workflows is directly relevant to SaaS roles in operations, compliance, and systems implementation, where scale depends on clean standards and measurable controls. Vendor evaluation, migration planning, and lifecycle management also build durable experience in enterprise platform rollouts.
This position is best suited to professionals who prefer ownership over a defined domain and are comfortable moving between strategy and hands-on execution. It will appeal to those who enjoy aligning stakeholders around shared operational standards and maintaining high-quality system hygiene over time, particularly in environments where external scrutiny shapes day-to-day priorities.
The section above is editorial commentary from The SaaS Jobs, provided to help SaaS professionals understand the role in a broader industry context.
Job Description
Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases. Guided by our core values, Stay True to Why, Collaborate to Accelerate, Lead with Clarity, Boldly Innovative, and Own the Outcome, we are committed to transforming the future of treatment for autoimmune disease. Join us at the forefront of cell therapy innovation and help redefine what’s possible.
Position Overview
Kyverna is seeking an Associate Director, TMF Lead to lead the strategy, build, and execution of an in-house Trial Master File function. This role will play a critical part in advancing our clinical programs by ensuring all study TMFs are consistently inspection-ready and aligned with global regulatory expectations. This individual will operate as both a strategic leader and hands-on expert, responsible for transitioning electronic TMF operations from an outsourced model to an integrated, scalable in-house capability. The role requires deep expertise in TMF structure, document quality, and lifecycle management, along with strong ownership of systems, processes, and cross-functional alignment.
Title: Associate Director, TMF Lead
Location: Remote eligible
Reports To: Sr. Director, Clinical Operations
Responsibilities
Lead the end-to-end TMF strategy, including the transition from outsourced to in-house operations, ensuring control, scalability, and quality across all clinical studies. Define and implement TMF governance, processes, and standards to ensure consistent document organization, classification, and filing in alignment with regulatory requirements and industry best practices. Serve as the TMF subject matter expert, establishing clear expectations for document structure, naming conventions, indexing, and lifecycle management. In partnership with Clinical Operations study lead, oversee TMF health across all studies, ensuring completeness, accuracy, and inspection readiness at all times through ongoing quality control and reconciliation. Lead TMF activities across the study lifecycle, including study start-up, maintenance, and close-out, ensuring proper documentation, completeness reviews, and archival readiness. Own and execute TMF migration efforts ensuring data integrity, completeness, and alignment with Kyverna standards. Assess and evaluate TMF system providers by defining requirements, conducting vendor assessments, and leading cross-functional reviews to identify a compliant, scalable, and inspection-ready solution. Partner closely with Clinical Operations, Clinical Development, Regulatory, Quality, IT and external partners to ensure seamless document flow and accountability. Operate comfortably in both strategy and execution, including direct involvement in document review, filing quality, and issue resolution. Establish TMF metrics and KPIs to proactively identify risks, drive continuous improvement, and ensure sustained inspection readiness. Support regulatory inspections and audits as the TMF lead, ensuring readiness and effective responses to health authority inquiries.
Qualifications
- Bachelor’s degree in life sciences or related field; advanced degree preferred.
- 10+ years of clinical research experience with a strong focus on TMF management.
- Proven experience leading TMF operations, including both strategic oversight and hands-on execution.
- Demonstrated experience transitioning TMF activities from outsourced to in-house models.
- Strong expertise in Veeva Vault eTMF, including implementation, migration, and ongoing management.
- Deep understanding of TMF structure, document taxonomy, and regulatory requirements (FDA, EMA, ICH-GCP).
- Experience managing TMF across the full study lifecycle, including close-out and archival.
- Experience leading TMF migration initiatives with a focus on quality and compliance.
- Experience in biotech or cell and gene therapy.
- Experience supporting regulatory inspections and audits.
- Experience building or scaling TMF capabilities within a growing organization.
The national salary range for this position is from $160,000 to $180,000 USD annually. This salary range is an estimate of what we reasonably expect to pay for this posted position, and the actual salary may vary based on various factors, including without limitation individual education, experience, tenure, skills and abilities, as well as internal equity and alignment with market data. This position is also eligible for bonus, benefits, and participation in Company’s stock plan.
