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 to restore immune tolerance and halt severe autoimmune and inflammatory disease. Tr1X is the first company to use an allogeneic engineered Tr1 cell therapy in clinical trials and is headquartered in San Diego, CA. For more information, 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. The VPCO establishes the strategic direction, operational integrity, and organizational capability of the Clinical Operations function, overseeing the design and execution of all clinical trials, vendor partnerships, and budget governance. The VPCO ensures scientific rigor, regulatory compliance, and operational excellence, mentors Clinical Operations staff, and provides executive‑level oversight, integrating the function into corporate strategy, long‑term portfolio planning, and investor 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 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, and quality—to ensure effective program execution and 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 fiscal responsibility.
Ensure all clinical trials comply with applicable regulatory agencies including FDA, EMA, and ICH requirements.
Serve as a subject‑matter expert and key representative of Clinical Operations, building strong 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.
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% of the 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, including 4+ years at VP‑level at a biotech or pharma company with executive oversight of multi‑program portfolios.
Proven ability to mentor and develop senior leaders (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 trials.
Expansive experience leading, managing, and contracting with CROs, clinical sites, vendors, and other study 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.
Experience with T‑cell immunotherapy trials preferred.
Proficiency in Microsoft 365 Office programs (Word, Excel, PowerPoint) and Trial Master File systems.
Other Requirements
Legally authorized to work for any employer in the United States.
Position is on‑site in San Diego, CA.
Travel is required, up to 25% of the 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 agility to tackle new challenges head‑on, fostering 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
Compensation and Benefits
Base salary.
Discretionary annual target bonus.
Incentive stock options.
401(k) retirement plan with company contribution.
Health and welfare insurance plans (medical, dental, vision, long‑term and short‑term disability, life insurance).
Paid time off (PTO) and paid holidays.
Employment and EEO Information 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 need 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. Unsolicited referrals and resumes are not accepted from employment agencies unless advance written authorization is granted by 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.
#J-18808-Ljbffr
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. The VPCO establishes the strategic direction, operational integrity, and organizational capability of the Clinical Operations function, overseeing the design and execution of all clinical trials, vendor partnerships, and budget governance. The VPCO ensures scientific rigor, regulatory compliance, and operational excellence, mentors Clinical Operations staff, and provides executive‑level oversight, integrating the function into corporate strategy, long‑term portfolio planning, and investor 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 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, and quality—to ensure effective program execution and 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 fiscal responsibility.
Ensure all clinical trials comply with applicable regulatory agencies including FDA, EMA, and ICH requirements.
Serve as a subject‑matter expert and key representative of Clinical Operations, building strong 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.
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% of the 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, including 4+ years at VP‑level at a biotech or pharma company with executive oversight of multi‑program portfolios.
Proven ability to mentor and develop senior leaders (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 trials.
Expansive experience leading, managing, and contracting with CROs, clinical sites, vendors, and other study 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.
Experience with T‑cell immunotherapy trials preferred.
Proficiency in Microsoft 365 Office programs (Word, Excel, PowerPoint) and Trial Master File systems.
Other Requirements
Legally authorized to work for any employer in the United States.
Position is on‑site in San Diego, CA.
Travel is required, up to 25% of the 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 agility to tackle new challenges head‑on, fostering 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
Compensation and Benefits
Base salary.
Discretionary annual target bonus.
Incentive stock options.
401(k) retirement plan with company contribution.
Health and welfare insurance plans (medical, dental, vision, long‑term and short‑term disability, life insurance).
Paid time off (PTO) and paid holidays.
Employment and EEO Information 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 need 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. Unsolicited referrals and resumes are not accepted from employment agencies unless advance written authorization is granted by 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.
#J-18808-Ljbffr