Vice President, Clinical Operations at Tr1x

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 Vice President, Head of Clinical Operations (VPCO) reports to the Chief Medical Officer (CMO) and serves as a core member of the Management Leadership Team, contributing to company-wide strategic planning and decision-making. The VPCO is a senior executive leader responsible for establishing and advancing the strategic direction, operational integrity and organizational capability of the Clinical Operations function.

This role provides both strategic vision and operational accountability across all clinical programs, ensuring alignment with corporate objectives. The VPCO evaluates and optimizes the organizational structure, systems and leadership capacity within Clinical Operations to ensure long-term scalability, efficiency, and compliance.

The VPCO oversees the design and execution of all clinical trials, including strategic vendor partnerships, budgetary governance, and collaboration with cross-functional leaders. As a subject matter expert and enterprise leader, the VPCO establishes governance frameworks, performance metrics, and operating standards that ensure scientific rigor, regulatory compliance, and operational excellence across Tr1X programs.

This role establishes executive-level oversight to the Clinical Operations function during a period of organizational growth. The VPCO ensures sustainable processes, leadership continuity, and operational excellence while mentoring existing Tr1X Clinical Operations professionals and preparing the department for long-term success.

The VPCO acts as the executive sponsor for Clinical Operations initiatives and ensures the function’s integration into corporate strategy, long-term portfolio planning, and investor-facing communications.

Key Responsibilities

Define and lead the clinical operations strategy in partnership with the CMO and Company leadership.
Oversee the design and execution of clinical trials in alignment with corporate goals, timelines, budgets, regulatory standards and patient safety and quality requirements.
Evaluate organizational capabilities and implement structural or process improvements to enhance scalability and operational efficiency.
Select, negotiate, and manage CROs and other key external partners, ensuring quality, fiscal discipline, and delivery excellence.
Allocate appropriate resources to support clinical program needs for both internal and outsourced activities.
Lead and collaborate with cross-functional colleagues including translational sciences, clinical development, regulatory affairs, manufacturing, project management, quality and others to ensure effective program execution and adherence to regulatory compliance.
Develop and maintain Clinical Operations infrastructure, including SOPs, study processes, databases, and tracking systems.
Build and lead a high-performing Clinical Operations team; set strategic priorities, develop senior leaders, and foster a culture of excellence and accountability.
Develop and oversee the Clinical Operations budget including clinical study budgets, expenditure tracking, cost-effective resource allocation, financial forecasting, and adherence to fiscal responsibility.
Ensure all clinical trials are conducted in accordance with applicable regulatory agencies including FDA, EMA, and ICH requirements.
Serve as a subject matter expert and key representative of Clinical Operations and build strong and highly collaborative relationships with internal and external stakeholders.
Oversee data integrity and reporting to ensure high-quality clinical trial outcomes for interim data read outs, clinical trial reports, publications, and presentations to internal and external stakeholders.
Regularly report key clinical metrics, operational risks, and mitigation strategies to the Executive Leadership Team and Board of Directors.
Drive change management initiatives that strengthen organizational capability and readiness for future growth.
Travel domestically to clinical sites as required, up to 25% time.
Perform other responsibilities based on business needs.

Required Qualifications & Experience

Bachelor’s degree in life sciences or related field or advanced nursing degree
Minimum 16 years of related clinical operations experience with 4+ years at VP-level at a biotech or pharma company including executive oversight and leadership of multi-program portfolios.
Proven ability to mentor and develop senior leaders (e.g., Executive Directors, Directors) within a complex, fast-paced biotech environment.
Extensive clinical trial execution and management experience across a broad range of studies, including early-phase clinical trials.
Expansive experience leading, managing and contracting with CROs, clinical sites, clinical vendors and other clinical study-related partners.
Demonstrated experience building clinical operations infrastructure, including SOPs, processes, and inspection readiness.
Advanced knowledge of FSA, ICH, EMA, IRB/IEC and GCP regulatory requirements.
Exceptional strategic and critical thinking and problem-solving skills.
Excellent organizational, interpersonal, and oral and written communication skills.
Ability to multi-task in a fast-paced, entrepreneurial environment and work collaboratively, under pressure, and with a sense of urgency.
Experience with T-cell immunotherapy trials preferred.
Proficiency in Microsoft 365 Office programs (e.g., Word, Excel, PowerPoint) and Trial Master File systems.

Other Requirements

Legally authorized to work for any employer in the U.S.
Position is on-site in San Diego, CA
Travel is required, up to 25% time

The job responsibilities and requirements provided above are intended to describe the general nature of the work performed by individuals assigned to this job classification. It is not intended to be an exhaustive list of all duties and requirements. Tr1X retains the right to add, change, or delete duties, education, experience or any other requirements of the position at any time.

Working at Tr1X

At Tr1X, our team is united by a singular shared mission: to transform patients’ lives through breakthrough science. We are a group of skilled experts driven by urgency, innovation and a collaborative spirit. Our culture thrives on excellence, positivity, persistence and the agility to tackle new challenges head-on. With an unwavering commitment to patients, science and one another, we foster an environment where team members feel engaged, supported and empowered to make a meaningful impact. We envision a world where autoimmune diseases are not just being treated but are cured.

Base Pay Range Anticipated: $300,000 - $340,000

Tr1X considers a variety of factors to determine salary such as education, years of experience, time in the position level, training, knowledge, skills, geographic location, and the market value of the position.

Compensation and Benefits

Tr1X provides a fair and competitive total rewards program that includes base salary; discretionary annual target bonus; incentive stock options; 401(k) retirement plan with company contribution; health and welfare insurance plans for employees (and their families) that include medical, dental, vision, long-term and short-term disability, and life insurance; paid time off (PTO); and paid holidays.

Tr1X embraces a diverse, open, and inclusive environment and believes a strong culture connection is key to success. Tr1X is committed to fairness in recruitment, hiring, transfer, promotion or any other employment practice without regard to race, color, citizenship, national origin, ancestry, religion, sex, pregnancy, marital status, sexual orientation, gender, gender identity and expression, age, physical and medical disability, medical condition, genetic information, political affiliation, protected veteran status, or any other characteristic protected by law. If you are an individual needing assistance to complete an employment application or would like to request an accommodation, please contact the Human Resources department at careers@tr1x.bio.

Notice to Employment Agencies

The Tr1X talent acquisition program is managed through internal resources, and unsolicited referrals and resumes are not accepted from employment agencies, unless advance written authorization is granted from the human resources department. Tr1X shall not be liable for any fees arising from any unsolicited or unauthorized candidate information received relative to position vacancies.