Act as a central contact for Clinical Study Teams for TMF management and participate in the development of quality oversight processes for TMF management of clinical trials.
Review and approve TMF documents, co-author and manage TMF documents such as TMF Plan and Index, and ensure quality management by reporting metrics and reconciling outstanding queries.
Oversee the activities of external vendors, ensuring study documents are adherent with ICH-GCP guidelines and regulatory requirements and that assigned studies are inspection-ready.
Lead the end-to-end TMF strategy, including the transition from outsourced to in-house operations.
Define and implement TMF governance, processes, and standards to ensure consistent document organization.
Serve as the TMF subject matter expert, establishing clear expectations for document structure.
Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases. Guided by our core values, we are committed to transforming the future of treatment for autoimmune disease.
Support operational execution of cell therapy clinical trials with a focus on vendor management and central laboratory oversight.
Ensure vendors deliver high-quality, timely services aligned with study timelines, budgets, and regulatory requirements.
Oversee site feasibility, selection, contracting, start-up, and close-out activities to support study milestones and program objectives.
Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases. Guided by core values of collaboration, clarity, innovation, and ownership, the team is committed to transforming the future of treatment for autoimmune disease.
Support the administrative execution of clinical trials, including document formatting, information review, and study status tracking.
Manage study-specific information using databases and tools, and assist in reviewing essential documentation like informed consent forms and study plans.
Coordinate clinical trial logistics such as supplies management, meeting setup, and sample movement between sites and laboratories.
Sumitomo Pharma America is a global pharmaceutical company focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies, and CNS. It has a diverse pipeline and aims to accelerate research to bring novel therapies to patients, operating within a fast-paced, collaborative environment driven by a mission for better healthcare.
Serve as the clinical lead for one or more clinical programs, with responsibility for clinical trial design, execution oversight, and delivery of key milestones.
Serve as medical monitor for assigned studies, including review of eligibility, protocol deviations, safety signals, SAEs/AEs, and benefit-risk assessments.
Contribute to global regulatory strategy and interactions with health authorities (FDA, EMA, PMDA, etc.).
Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities. They are a fully remote company headquartered in Radnor, Pennsylvania, with a culture that emphasizes collaboration and high-quality execution.