About Tr1X Tr1X is a clinical-stage biotechnology company developing engineered Tr1 cell therapies to restore immune balance in autoimmune and inflammatory diseases. Leveraging the unique biology of Tr1 cells, the company is advancing a pipeline of off-the-shelf allogeneic and in vivo CAR-Tr1 therapies designed to deliver targeted immunoregulation and address diseases driven by immune dysfunction, including transplant-related complications. Founded by pioneers in the discovery of Tr1 cells, Tr1X, Inc.

is focused on developing durable, potentially curative therapies for conditions with high unmet need. bio. Position Summary The Director, Clinical Operations provides strategic leadership and operational oversight for the implementation and execution of clinical trials from study start-up through close-out.

Requirements

, GCP guidelines, and internal SOPs. This role serves as a key operational leader within the organization and is responsible for mentoring, developing, and supervising clinical operations personnel.

Key Responsibilities

Provide strategic leadership as the Clinical Study Lead for cross-functional teams to ensure study start-up, enrollment, maintenance, and close-out activities are executed on schedule, within budget, and in accordance with quality expectations. Direct and oversee all aspects of clinical study management to ensure operational excellence, inspection readiness, and delivery of high-quality clinical data. Lead the clinical operational development, review, and finalization of clinical trial protocol synopses, protocols, protocol amendments, and other key study-related documents.

Lead the CRO and vendor selection strategy for outsourced activities, including RFP development, bid management, proposal evaluation, budget negotiations, and executive-level vendor selection decisions. Direct negotiation, execution, and oversight of contracts and scopes of work with CROs, study vendors, consultants, and investigative sites. Oversee the development and maintenance of critical study documents, including informed consent templates, management plans, study trackers, and operational plans, ensuring appropriate delegation and accountability.

Chair and lead internal and external clinical study meetings, governance reviews, and cross-functional operational discussions, ensuring alignment of objectives, decisions, and action items. Partner strategically with Regulatory Affairs to ensure timely preparation and submission of site essential regulatory documentation to the FDA and other regulatory authorities. Develop and oversee clinical monitoring strategies and monitoring plans to ensure compliance, quality oversight, and operational consistency across studies and vendors.

Provide strategic oversight for case report form (CRF) design, edit check development, and data collection methodologies in partnership with Data Management and Clinical Development. Lead site initiation planning and execution activities, including oversight of training materials, presentations, and investigator engagement strategies. Provide leadership and governance oversight of CROs, field monitors, and clinical vendors to ensure contractual obligations, quality metrics, and operational deliverables are achieved.

Establish oversight processes for monitoring visit reports, protocol deviations, CAPAs, and action item resolution to ensure quality and compliance standards are maintained. Direct and oversee study-wide operational activities including vendor management, biospecimen handling, investigational product logistics, investigator payments, data quality oversight, and centralized records management.