Director, Clinical Operations (Autoimmune)

Janux Therapeutics seeks a Director of Clinical Operations to lead early-phase autoimmune clinical trials from its newly announced Adaptive Immune Response Modulator platform. The incumbent will provide trial operational oversight of CROs and vendors (including both U.S. and Ex-U.S. regions) and will be responsible for all aspects of assigned clinical trials. This role also assures adherence to GCP, regulations and applicable procedures, in addition to protocol compliance and that of study related plans.

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES

• Independently manage all components of complex early phase autoimmune clinical trials
• Ensure clinical trial activities and deliverables are completed on-time and within budget
• Vendor (e.g., CRO, Biometrics, IXRS, PK/Central Lab, eTMF, Safety) oversight for adherence to budget, timelines, and organizational objectives of individual protocols/programs.
• Involved in the identification, evaluation, selection, and oversight of all clinical trial sites.
• Develops strong vendor and ensures continuity of relationships through all phases of the trial.
• Partner efficiently and effectively with clinical trial sites to ensure smooth study conduct
• Ensure efficient study enrollment and high-quality monitoring activities at participating clinical sites
• Manages vendors through issue resolution
• Obtains and maintains in-depth understanding of the study protocol and related procedures to contribute strongly to study team knowledge by sharing best practices, making recommendations for continuous improvement, and providing training as appropriate/required.
• Oversee and participate in development of study documents and tools including study protocols, consent forms, and project plans
• Coordinates & manages various tasks in collaboration with other sponsor roles to achieve site readiness, such as study materials and approval for drug shipping/receipt according to procedure.
• Participates in Site Initiation Visits
• Develop processed and provide oversight of study supplies management
• Performs timely review of monitoring reports from CRO and associated deliverables demonstrating sponsor oversight.
• Oversee ongoing study data reviews and data cleaning activities.
• Responsible for inspection readiness at all times. Perform periodic reviews of the CRO eTMF/TMF to ensure adherence with standards and compliance with the relevant regulations and guidelines.
• Works with vendors to revise scope of service agreements, budgets, plans and detailed timelines, and ensure that performance expectations are met.
• Supports financial management of the study which includes review and approval of site and vendor invoices.
• Supports Risk Management initiatives
• Supports audit/inspection activities as needed.
• Maintain clinical trial registry entry/updates, as required.
• Provides mentorship/guidance to junior team members or cross-functional colleagues on study processes/study requirements
• Conduct/attend internal/external meetings for assigned clinical trials
• Provide study status updates, including presentations and reports to senior management
• May develop SOPs, best practices, and facilitate their implementation
• May perform periodic oversight visits of sites and/or vendors to assess progress and compliance.
• Other activities as assigned

REQUIRED EDUCATION, EXPERIENCE, SKILLS, AND ABILITIES

• BA/BS in related scientific or healthcare field, a combination of relevant education and applicable job experience may be considered
• Minimum 8 years of clinical trial management experience; a total of 12 to 14 years of clinical research experience is required
• Previous phase I autoimmune experience required and experience with immunotherapies/biologics is preferred
• Experience in running a trial from start to finish; initiating the trial; ICF generation, site feasibility/start up training, contract and budget negotiation, vendor management, CRF design, maintaining a trial and study close out.
• Excellent communication skills, including the ability to understand and present technical information effectively
• Strong understanding and working knowledge of clinical research, phases of clinical studies, current ICH GCP, FDA regulations, & country clinical research law & guidelines.
• Strong understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.
• Demonstrated ability to mentor/lead.
• Strong leadership, effective decision making, and problem-solving skills required
• Hands on knowledge of Good Documentation Practices.
• Performs independently and professionally when manag