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 critically with a keen sense of urgency in a fast-paced environment.
• Experience in the conduct of pre-NDA, Phase 1 first-in-human clinical trials to include trial set-up, monitoring, and close out.
• Experience with electronic systems such as eTMF, CTMS, EDC, etc.
• Ability to work independently and within a cross-functional team structure.
• Excellent professionalism, integrity, interpersonal, written and verbal communication, computer, organizational and administrative skills.

Other Requirements

• Legally authorized to work for any employer in the U.S.
• Travel is required up to 15%.
• The 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 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.