Associate Director, Clinical Quality

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 Quality (ADCQ) is a key member of the Quality team ensuring the Tr1X clinical practices meet the highest standards of quality, compliance, and continuous improvement and aligned with industry standards and all applicable regulations (local, state, FDA, and other relevant agencies). The ADCQ reports to the Executive Director, Quality and is responsible for all aspects of Clinical Quality. The ADCQ leads GCP compliance strategies and is an integral part of all clinical program teams. The ADCQ works with both internal and external stakeholders to meet timelines and internal deliverables and is a partner with the clinical program teams to ensure regulatory compliance is achieved. The person in the ADCQ role is someone who has broad and diverse knowledge of clinical quality in support of clinical program objectives. The responsibilities of this position require the ADCQ to be highly collaborative and possess advanced interpersonal and influencing skills.

Key Responsibilities

• Oversee all aspects of Clinical Quality for internal and external processes, including CROs, vendors, and investigator sites.
• Review internal and external documentation to ensure quality, regulatory compliance and audit-readiness.
• Document internal regulatory processes and evaluate quality events, incidents, queries, and complaints.
• Utilize guidance regulatory documents, international standards, and industry standards and interpret and apply to clinical trials and activities.
• Conduct audits of clinical documentation, investigator sites, vendors, systems.
• Lead root cause analyses and implement corrective and preventive action plans.
• Collaborate with internal and external stakeholders to align quality strategies with organizational goals.
• Assume a lead role in representing clinical quality at internal meetings and in preparing and drafting clinical quality policies, procedures, regulatory submissions and GCP training.
• Communicate any critical compliance risks to senior management and recommend possible solutions.
• Assist in the development of documentation and implementation of systems and SOPs.
• Support all Quality team needs as identified by management.
• Keep abreast of and make recommendations to management on new or revised regulations, guidelines, points to consider, compliance guides, inspection reports, journals, meetings, etc.
• Perform other responsibilities as required by business needs.

Required Qualifications & Experience

• Bachelor’s degree in a scientific discipline or an equivalent combination of education, training and/or experience from which comparable knowledge, skills and abilities have been attained.
• Minimum 8 years of related experience with a minimum 5 years of experience in clinical quality management in the pharmaceutical or biotech industry.
• Experience and knowledge in the establishment and management of quality systems, vendor and investigator site audits, and CRO oversight.
• Working knowledge and adherence to FDA, ISO and ICH regulatory guidance and regulations, clinical quality operations, and CTD/eCTD standards.
• Exceptional interpersonal skills with the ability to effectively develop supportive and collaborative relationships.
• Superior organizational, communication, and problem-solving skills.
• Highly proficient in MS Office 365 (with an emphasis on MS Word).

Other Requirements

• Experience with cell therapy products and prior participation in regulatory inspections desirable.
• Legally authorized to work for any employer in the U.S.
• Periodic travel is required to CROs and vendor sites.
• Position is based in San Diego, CA.

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: $175,000 - $200,000

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 [email protected].

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.