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Janux Therapeutics

Posted 4 months ago

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Senior Director, Clinical Operations (autoimmune)

San DiegoHybridFull-time

AI Summary

The Senior Director of Clinical Operations provides global operational leadership for complex clinical programs in autoimmune diseases, overseeing trial execution, cross-functional collaboration, and team mentorship to ensure on-time, on-budget delivery in a fast-paced environment.

About this role

The Senior Director of Clinical Operations will provide global operational leadership overseeing complex clinical programs focusing on innovative T-cell engager therapies for immunology indications. This role is responsible for efficient planning, resourcing and execution of portfolio level programs in adherence to ICH-GCP, FDA regulations, and company SOPs. The Senior Director will report into the Vice President, Clinical Operations and will ensure strategic alignment of programs and key stakeholder management in a fast-paced environment, while mentoring and growing the Clinical Operations team and culture to ensure successful program delivery.

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES

  • Drive global clinical operations strategy and execution for programs ensuring all clinical activities support IND-enabling -Phase 3 objectives, as well as future clinical development plans.
  • Collaborate effectively cross-functionally with senior leadership to ensure operational initiatives support strategic company goals.
  • Establish and refine scalable best practices to drive efficiency while preparing for future departmental growth.
  • Oversee the development, review, and operational implementation of study documents, including protocols, informed consent forms, CRFs, monitoring plans, and pharmacy manuals ensuring consistency among programs.
  • Responsible for successful external partner relationships including CROs, central labs, patient advocacy groups and others. Ensure deliverables are met on time, within budget, and to quality standards.
  • Prepare and deliver program updates, establish KPIs and dashboards, and effectively present to all study teams. Strongly represent Clinical Operations in internal and external meetings.
  • Mentor and support direct reports, fostering professional development, team performance and a strong culture.
  • Oversee site strategy and establish Clinical Operations team relationships with investigators and key opinion leaders.
  • Contribute to the development and implementation of SOPs, work instructions, and operational plans to enhance team efficiency and compliance.
  • Develop and implement operational plans, timelines, and budgets for clinical programs.
  • Ensure all trial activities are conducted in accordance with the protocol, SOPs, GCP, and applicable regulations.

    • REQUIRED EDUCATION, EXPERIENCE, SKILLS, AND ABILITIES

  • Bachelor’s degree in life sciences or related field with 12+ years of experience in clinical research, including at least 10 years in clinical trial management. Advanced degree preferred.
  • Strong experience in complex autoimmune indications, early phase experience strongly preferred.
  • Ability to define strategy and ensure organizational goals are executed in global clinical operations plans.
  • Proven track record of leading complex clinical programs from start to completion.
  • Strong knowledge of ICH GCP, FDA regulations, and global clinical regulatory guidelines.
  • Strong IT skills in MS Office and clinical trial systems (e.g., CTMS, eTMF, EDC).
  • Expertise in clinical budgeting and efficient allocation of resources
  • Demonstrated success in leading, mentoring, developing diverse clinical teams and providing oversight to CROs.
  • Excellent communication, leadership, and interpersonal skills, including the ability to understand and present technical information effectively to executive leadership.
  • Strong organizational and time management abilities.
  • High level of accountability, adaptability, and attention to detail with an ability to set priorities and handle multiple tasks simultaneously in a changing environment.
  • Ability to work independently and collaboratively in a fast-paced, matrixed environment.

    • Skills

    Clinical BudgetingClinical Trial SystemsCTMSEDCETMFFDA RegulationsICH-GCPMicrosoft OfficeSOPs

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