Position Description

The Senior Clinical Trial Manager (CTM) at Tr1X will be at the forefront of our early phase studies using allogeneic Treg cell therapies, working in a high-paced, growth-focused startup environment. This role is ideal for someone who thrives on direct feedback, is passionate about continuous learning, and is eager to tackle significant responsibility from day one. You will be a key contributor to implementing and executing clinical trials from start-up to close-out, while being part of a close-knit, agile team that aims to accelerate the development of Tr1X’s next-generation cellular therapies. The Sr. CTM will manage and oversee CROs, study vendors, and clinical trial sites, and will partner with internal stakeholders to ensure on-time, within-budget clinical trial deliverables in accordance with regulatory requirements, GCP guidelines, and internal SOPs. If you’re excited about growth opportunities, bringing novel cell therapies to patients, and want a seat at the table in a collaborative, fast-paced startup, we encourage you to apply.

The Impact You’ll Make

• Study Leadership: Serve as the Study Lead to the multifunctional team for our complex Phase 1/2a cell therapy studies. Oversee study start-up, enrollment, maintenance, and close-out to ensure delivery on time and on budget.
• Data Quality: Oversee aspects of study management to ensure execution accuracy and high-quality data for all clinical studies under your guidance.
• Protocol Development: Generate clinical trial protocol synopsis, protocols, and protocol amendments in collaboration with the Senior Director of Clinical Operations and CMO.
• Vendor Selection & Oversight: Facilitate CRO/vendor selection for outsourced activities, including developing RFPs, managing the bidding process, analyzing proposals, budgets, and leading and documenting vendor selection decisions. Oversee review of scope of work, budgets, and negotiate contracts through execution.
• Contract Management: Procure and manage contracts with CROs, study vendors, and investigative sites, taking full ownership of quality and timelines.
• Critical Documentation: Develop critical study documents (e.g., informed consent forms, management plans, study trackers). You may delegate development to CROs, but you’ll maintain ultimate responsibility for their quality.
• Project Coordination: Assist with or lead the development of internal meeting agendas, meeting minutes, and communication plans to keep all stakeholders aligned on trial progress.
• Essential Trial Documents: Develop, distribute, review, and track essential trial documents and/or oversee CRO responsibility for these tasks. Provide Regulatory Affairs with site essential regulatory documents for submissions to the FDA and other agencies.
• Monitoring & Compliance: Develop and ensure compliance with clinical monitoring plans; conduct or oversee co-monitoring for staff training and QA as needed.
• CRF Design: Partner in the case report form (CRF) design process, including content, form layout, and edit-check reviews.
• Site Initiation: Participate in developing and presenting site initiation materials, including site initiation slide decks and visits.
• Drug Supply Management: Liaise with the CMC team to forecast and monitor overall drug supply and expiration to ensure continuous availability throughout the study.
• Regulatory File Maintenance: Maintain complete, updated regulatory files for assigned sites. Manage safety reporting to sites and regulatory agencies.
• CRO & Vendor Oversight: Manage or provide oversight of CROs, independent field monitors, and other clinical vendors; ensure monitoring trip reports are reviewed, and track protocol deviations and action items through resolution.
• Study-Wide Management: Oversee or directly manage study-wide activities such as external vendors, sample handling, drug re-supply, investigator payments, data quality, and central records quality. Serve as the in-house contact for protocol-related questions.
• Data Review & Audit: Audit clinical data reports for accuracy, safety, and/or efficacy trends; prepare and present analyses as needed.
• Process Improvement: Contribute to the ongoing development and review of SOPs. Ensure Trial Master File (TMF) is properly maintained throughout the study life cycle.
• Team Leadership: Manage direct reports, assign and monitor tasks, and provide frequent study updates to senior management. May participate in or lead internal clinical program meetings, investigator calls, and safety review committee calls.
• Growth & Collaboration: Embrace a culture of direct feedback, continuous learning, and proactive communication. Seek opportunities to expand knowledge, mentor others, and drive process improvements that support company growth.
• Other Duties: Perform additional tasks as assigned, in line with your expanding skills and experience.

The Team – Yes, You Belong!

We are building a diverse, bold, agile, and collaborative organization where each team member works closely and communicates respectfully with each other. Tr1X leadership has high expectations for themselves and for you—and so should you! We expect everyone to be deeply focused on bringing Tr1X’s cellular therapies to patients at an accelerated pace. This environment is fast-moving, direct, and energetic. If you’re someone who embraces feedback, seeks to learn, and wants to step into a role with broad responsibilities, you’ll fit right in.

You Have and You Are

• Education & Experience: A Bachelor’s degree with at least 5 years of hands-on clinical trial experience, preferably in a pharmaceutical or biotech environment. A combination of CRO and pharma/biotech experience will be considered.
• Cell & Gene Therapy Expertise: Experienced in cell and/or gene therapy with a strong working knowledge of ICH/GCP regulations.
• Professionalism & Integrity: Displays honesty, professionalism, and respect in all interactions with colleagues, vendors, and leadership. Demonstrates adaptability and a collaborative, “can-do” attitude in a fun, collegial environment.
• Self-Starter: Motivated, driven, and hungry for knowledge. Takes initiative, actively seeks learning opportunities, and tackles challenges with enthusiasm.
• Critical Thinking & Urgency: Able to plan, prioritize, mitigate risk, and think critically in a fast-paced startup setting.
• Early-Phase Trial Experience: Adept at conducting pre-NDA, Phase 1 First-in-Human clinical trials, including trial setup, monitoring, and close-out.
• Technical Proficiency: Experience with electronic systems such as eTMF, CTMS, EDC, etc.
• Independent & Team-Oriented: Able to work autonomously after onboarding and thrive within a collaborative team structure.
• Exceptional Communication: Possesses excellent interpersonal, written, and verbal communication skills. Demonstrates strong computer, organizational, and administrative capabilities.
• Willingness to Travel: Up to 15% or more travel may be required.
• Willingness to be on-site: Able to work on-site in our San Diego office at least 80% time.
• Work Authorization: Legally entitled to work for any employer in the US.
• Major Bonus Points: If you’ve worked in Graft versus Host Disease, or stem cell/bone marrow transplant before

We Offer:

In addition to a competitive compensation package with stock options and a performance-based bonus, Tr1X offers comprehensive benefits for our employees and their families including:

• Medical
• Dental
• Vision
  
• Flexible Spending Account (FSA) 
• Life & AD&D Insurance
• Generous Paid Time Off
• 401(k) with employer match
• On-site gym & wellness facilities

Compensation range for this position: $130,000-$160,000. Actual amounts will vary depending on experience, performance and aptitude.

If you’re energized by the opportunity to take on big responsibilities, eager to learn in a fast-paced startup environment, and excited to help shape the future of cell therapy for autoimmune diseases, we want to hear from you! Join us at Tr1X and make a lasting impact on patients’ lives.