Tr1X
biotechnology
Director,ClinicalOperations
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“Director, Clinical Operations at Tr1X. Skills: strategic leadership, operational oversight, clinical trial management, cross-functional team leadership, CRO and vendor management, budget management, regulatory compliance, GCP guideline adherence, SOP adherence, personnel mentoring and development. Provide strategic leadership and operational oversight for clinical trial implementation and execution.. Lead cross-functional clinical study teams.”
Industry & Context.
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%.
What They're Looking For.
Must Have
Experience with process management, Experience with cross-functional coordination, Experience with vendor/stakeholder management, Experience with operational metrics, Experience with resource planning, Experience with continuous improvement
What You'll Do.
Provide strategic leadership and operational oversight for clinical trial implementation and execution.
Lead cross-functional clinical study teams.
Direct contract research organizations (CROs)
and investigative sites.
Ensure clinical trial activities align with corporate objectives
regulatory requirements
and supervise clinical operations personnel.
Ensure study start-up
and close-out activities are executed on schedule
and in accordance with quality expectations.
Oversee all aspects of clinical study management for operational excellence
and high-quality clinical data delivery.
Lead the clinical operational development
and finalization of clinical trial protocol synopses
and other key study-related documents.
Lead the CRO and vendor selection strategy
including RFP development
and executive-level vendor selection decisions.
and oversight of contracts and scopes of work with CROs
and investigative sites.
Oversee the development and maintenance of critical study documents.
Chair and lead internal and external clinical study meetings
and cross-functional operational discussions.
Partner strategically with Regulatory Affairs for timely preparation and submission of site essential regulatory documentation.
Develop and oversee clinical monitoring strategies and monitoring plans.
Provide strategic oversight for CRF design
edit check development
and data collection methodologies.
Lead site initiation planning and execution activities.
Provide leadership and governance oversight of CROs
and clinical vendors.
Establish oversight processes for monitoring visit reports
and action item resolution.
Direct and oversee study-wide operational activities including vendor management
investigational product logistics
investigator payments
data quality oversight
and centralized records management.
Lead the review and analysis of clinical data reports to identify operational
and efficacy trends and communicate findings.
Ensure Trial Master File (TMF) oversight and inspection readiness.
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
and process optimization initiatives.
Proactively identify operational risks and implement mitigation strategies.
Perform additional strategic and operational responsibilities as required.
How You'll Work.
Team & Collaboration
Lead cross-functional clinical study teams.; Chair and lead internal and external clinical study meetings, governance reviews, and cross-functional operational discussions.; Partner strategically with Regulatory Affairs.; Provide strategic oversight for CRF design, edit check development, and data collection methodologies in partnership with Data Management and Clinical Development.; Partner with departmental leadership to define and execute clinical development operational strategies, resource planning, and process optimization initiatives.; Foster a culture of accountability, collaboration, operational excellence, and continuous improvement.
Communication Scope
Communicate findings to cross-functional leadership and governance committees.
Process & Methodology
clinical trial implementation, clinical trial execution, study start-up, enrollment, study maintenance, study close-out, CRO management, vendor management, budget management, timeline management, risk management
Full Job Description
About Tr1X 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 stra
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