Associate Director, Clinical Operations

About Tr1X

Tr1X is a private, clinical-stage biotechnology company focused on developing a novel class of regulatory T cell-based products to cure autoimmune and inflammatory diseases. Founded by industry experts, including the scientists who discovered Type 1 regulatory T (Tr1) cells, the company is developing a pipeline of off-the-shelf allogeneic cell therapies for autoimmune diseases with high unmet medical need. Our TRX cells are designed to mimic the function of naturally occurring Tr1 cells, which work to restore immune tolerance, stopping severe autoimmune and inflammatory disease in its tracks. Tr1X is the first company ever to use an allogeneic engineered Tr1 cell therapy in clinical trials. Tr1X is headquartered in San Diego, CA. For more information, please visit www.tr1x.bio.

Position Summary

The Associate Director, Clinical Operations (AD) is a key contributor in the implementation and execution of clinical trials from study start up to close-out. The AD has responsibility for the management and oversight of contract research organizations (CROs), study vendors and clinical trial sites, and partners with key internal stakeholders to ensure clinical trial deliverables are completed on-time, within budget, and in accordance with regulatory requirements, GCP guidelines and internal SOP’s.

Key Responsibilities

• Serve as a Study Lead to the multifunctional team to ensure clinical study activities including study start-up, enrollment, maintenance and close-out are executed based on the timeline and budget.
• Oversee aspects of study management for accurate study execution to ensure high quality data.
• Assist or generate clinical trial protocol synopsis, protocols and protocol amendments.
• Facilitate the CRO selection process for outsourced activities including developing an RFP, managing the bidding process, analyzing proposals and budgets, and leading and documenting vendor selection decisions.
• Procure and manage contracts with CROs, study vendors and investigative sites.
• Develop critical study documents or oversee delegation to CRO including informed consent form templates, management plans and study trackers.
• Assist and lead development of internal meeting agendas and meeting outcomes.
• Develop, distribute, review and track essential trial documents and/or oversee CRO responsibility.
• Provide Regulatory Affairs with Site Essential Regulatory Documents for submission to the FDA and other regulatory agencies.
• Develop and ensure compliance with clinical monitoring plan; conduct or oversee co-monitor as needed for staff training and quality assurance purposes.
• Partner in the development of the case report form design process including content, form layout, and edit check review.
• Partner in development and participate in site initiation slides and visits.
• Liaise with the chemistry, manufacturing, and controls (CMC) team to forecast and monitor overall drug supply and expiration to ensure adequate availability throughout trial.
• Maintain a complete and updated regulatory file for each assigned site.
• Manage safety reporting to sites and regulatory agencies.
• Manage or provide oversight of CROs, independent field monitors and other clinical vendors.
• Ensure monitoring trip reports are reviewed and track resolution of all action items and protocol deviations.
• Manage or oversee other study-wide activities such as external vendors, sample handling, drug re-supply, investigator payments, overall data quality, and overall central records quality.
• Serve as in-house contact for protocol related process questions.
• Audit clinical data reports for accuracy, safety, and/or efficacy trends; prepare related presentations.
• Contribute to SOP development and/or review process.
• Ensure Trial Master File is maintained throughout the study.
• Provide frequent study updates to senior management upon request.
• Participate and/or lead internal clinical program meetings, Investigator calls and/or Safety Review committee calls.
• Work with department head on developing study strategy and processes.
• Perform other responsibilities based on business needs.

Required Qualifications & Experience

• S. degree with a minimum 8 years of related experience and a minimum 5 years of direct study management experience.
• Experience in cell and/or gene therapy trials is preferred, particularly in Inflammatory Bowel Disease or other autoimmune indications.
• Strong working knowledge of ICH/GCP regulations.
• Adaptable self-starter team player who is willing to learn, ask questions and take initiative.
• Ability to plan, prioritize, mediate and think critic