Director, Clinical Operations

Tr1X, Inc.; San Diego (CA); Sur place; USD 210 000 - 230 000; Plein temps

Avantages offerts par ce poste

401k match

Health insurance

PTO

Stock options

Paid holidays

Résumé du poste

Tr1X, Inc. in San Diego, CA is seeking a Director of Clinical Operations to lead trials from start-up to close-out, manage CRO partners, investigators, and vendors, and ensure trials meet GCP, regulatory, and budget goals.

You will mentor a team, shape study conduct strategies, oversee TMF readiness, and collaborate with Regulatory Affairs to prepare essential submissions, while traveling up to 15% to sites and vendors as needed.

Qualifications

• A minimum of 10 years in clinical operations with at least 5 years in sponsor study leadership.
• Experience leading global or multi-center trials across development phases.
• Exposure to cell or gene therapy trials is preferred.
• Strong knowledge of ICH/GCP, FDA regulations, and global requirements.

Responsabilités

• Provide strategic leadership for cross-functional teams to ensure timely trial start-up, enrollment, and close-out within budget and quality expectations.
• Direct and oversee all aspects of clinical study management for operational excellence and inspection readiness.
• Lead protocol development, amendments, and key study documents with sponsor and CROs.
• Develop CRO/vendor selection strategies, bids, budgets, and executive-level decisions.
• Negotiate contracts and scopes of work with CROs, vendors, and sites.
• Maintain critical study documents and TMF oversight, ensuring accountability and delegation.
• Chair internal and external study meetings and governance reviews.
• Partner with Regulatory Affairs for timely regulatory submissions to FDA and authorities.
• Develop monitoring strategies and data collection methodologies with Data Management and Development teams.
• Oversee site initiation, training materials, and investigator engagement plans.
• Provide governance oversight of CROs, monitors, and vendors to meet contractual obligations.
• Establish monitoring and CAPA processes to maintain quality and compliance.
• Direct study-wide operations including biospecimen handling, logistics, and investigator payments.
• Review data reports to identify trends and communicate to leadership committees.
• Ensure TMF readiness and inspection readiness throughout studies.
• Lead and facilitate program meetings, safety reviews, and cross-functional forums.
• Define operational strategies with leadership for resource planning and process optimization.
• Identify operational risks and implement mitigation to ensure continuity.
• Travel up to 15% to clinical sites and vendors.
• Foster accountability, collaboration, and continuous improvement in a fast-paced environment.
• Perform additional duties to support evolving business objectives.

Connaissances

Clinical operations leadership

Cross-functional leadership

Vendor management

Regulatory knowledge (FDA/ICH/GCP)

Trial management (start-up to close‑up

Pre-NDA / first-in-human experience

Eclinical systems (eTMF, CTMS, EDC)

Strategic planning

Mentoring teams

Communication skills

Formation

Bachelor’s degree in science or healthcare field

Outils

eTMF

CTMS

EDC

Description du poste

Tr1X is a clinical-stage biotechnology company developing engineered Tr1 cell therapies to restore immune balance in autoimmune and inflammatory diseases. Leveraging the unique biology of Tr1 cells, the company is advancing a pipeline of off-the-shelf allogeneic and in vivo CAR-Tr1 therapies designed to deliver targeted immunoregulation and address diseases driven by immune dysfunction, including transplant-related complications. Founded by pioneers in the discovery of Tr1 cells, Tr1X, Inc. is focused on developing durable, potentially curative therapies for conditions with high unmet need. For more information, visit www.tr1x.bio.

Position Summary

The Director, Clinical Operations provides strategic leadership and operational oversight for the implementation and execution of clinical trials from study start-up through close-out. The Director is accountable for leading cross-functional clinical study teams; directing contract research organizations (CROs), study vendors, and investigative sites; and ensuring all clinical trial activities are executed in alignment with corporate objectives, timelines, budgets, regulatory requirements, GCP guidelines, and internal SOPs. This role serves as a key operational leader within the organization and is responsible for mentoring, developing, and supervising clinical operations personnel.

Key Responsibilities

• Provide strategic leadership as the Clinical Study Lead for cross-functional teams to ensure study start-up, enrollment, maintenance, and close-out activities are executed on schedule, within budget, and in accordance with quality expectations.
• Direct and oversee all aspects of clinical study management to ensure operational excellence, inspection readiness, and delivery of high-quality clinical data.
• Lead the clinical operational development, review, and finalization of clinical trial protocol synopses, protocols, protocol amendments, and other key study-related documents.
• Lead the CRO and vendor selection strategy for outsourced activities, including RFP development, bid management, proposal evaluation, budget negotiations, and executive-level vendor selection decisions.
• Direct negotiation, execution, and oversight of contracts and scopes of work with CROs, study vendors, consultants, and investigative sites.
• Oversee the development and maintenance of critical study documents, including informed consent templates, management plans, study trackers, and operational plans, ensuring appropriate delegation and accountability.
• Chair and lead internal and external clinical study meetings, governance reviews, and cross-functional operational discussions, ensuring alignment of objectives, decisions, and action items.
• Partner strategically with Regulatory Affairs to ensure timely preparation and submission of site essential regulatory documentation to the FDA and other regulatory authorities.
• Develop and oversee clinical monitoring strategies and monitoring plans to ensure compliance, quality oversight, and operational consistency across studies and vendors.
• Provide strategic oversight for case report form (CRF) design, edit check development, and data collection methodologies in partnership with Data Management and Clinical Development.
• Lead site initiation planning and execution activities, including oversight of training materials, presentations, and investigator engagement strategies.
• Provide leadership and governance oversight of CROs, field monitors, and clinical vendors to ensure contractual obligations, quality metrics, and operational deliverables are achieved.
• Establish oversight processes for monitoring visit reports, protocol deviations, CAPAs, and action item resolution to ensure quality and compliance standards are maintained.
• Direct and oversee study-wide operational activities including vendor management, biospecimen handling, investigational product logistics, investigator payments, data quality oversight, and centralized records management.
• Lead the review and analysis of clinical data reports to identify operational, safety, and efficacy trends and communicate findings to cross-functional leadership and governance committees.
• Ensure Trial Master File (TMF) oversight and inspection readiness throughout the duration of all assigned studies.
• Lead and facilitate internal clinical program meetings, investigator meetings, safety review committees, and other cross-functional governance forums.
• Partner with departmental leadership to define and execute clinical development operational strategies, resource planning, and process optimization initiatives.
• Proactively identify operational risks and implement mitigation strategies to ensure study continuity, compliance, and successful execution.
• Travel to clinical sites, investigator meetings, and vendor locations as required, up to 15%.
• Foster a culture of accountability, collaboration, operational excellence, and continuous improvement within a fast-paced, dynamic clinical development environment.
• Perform additional strategic and operational responsibilities as required to support evolving business and clinical development objectives.

Required Qualifications & Experience

• Bachelor’s degree in a scientific or healthcare-related discipline with a minimum of 10 years of progressive clinical operations experience, including at least 5 years of direct sponsor clinical study management and leadership experience.
• Demonstrated leadership experience managing complex global or multi-center clinical trials across multiple phases of development.
• Experience in cell and/or gene therapy clinical trials preferred, particularly within Multiple Sclerosis, Inflammatory Bowel Disease, or other autoimmune indications.
• Extensive working knowledge of ICH/GCP guidelines, FDA regulations, and global clinical trial regulatory requirements.
• Proven ability to lead cross-functional teams, influence stakeholders, and drive strategic clinical operations initiatives in a fast-paced environment.
• Strong operational leadership skills with demonstrated expertise in study start-up, trial execution, vendor oversight, risk management, and inspection readiness.
• Experience supporting pre-NDA programs and Phase 1 first-in-human clinical trials, including operational strategy, study oversight, monitoring, and close-out activities.
• Advanced experience with clinical trial systems including eTMF, CTMS, EDC, safety databases, and other clinical technologies.
• Exceptional strategic thinking, problem-solving, organizational, communication, and executive presentation skills.
• Ability to independently manage competing priorities while leading within a matrixed cross-functional organizational structure.
• Demonstrated success mentoring and developing high-performing clinical operations teams.
• High level of professionalism, integrity, accountability, and business acumen.

Other Requirements

• Legally authorized to work for any employer in the U.S.
• Travel is required up to 15%.
• The position is based on-site 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: $210,000 - $230,000

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 [e-mail].

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.