Director, Clinical Operations

Role Summary

The Director of Clinical Operations will provide strategic and operational leadership for our early phase oncology programs. This role will be responsible for end-to-end management of clinical trial activities, ensuring alignment with Janux Therapeutics’ mission to advance innovative oncology therapies. This includes oversight of contract research organizations (CROs), vendors, and clinical sites across both U.S. and international regions. The role will report into the Vice President, Clinical Operations and requires a deep understanding of clinical trial processes, regulatory compliance (GCP, FDA, ICH), and the ability to lead cross-functional teams to ensure high-quality, timely, and cost-effective trial execution.

This role offers a unique opportunity to contribute to the development of cutting-edge cancer therapies in a dynamic and mission-driven environment.

Responsibilities

• Own the operational strategy and execution for early phase oncology program, ensuring all clinical activities support IND-enabling objectives and future clinical development plans.
• Lead cross-functional teams (Clinical Development, Regulatory Affairs, Medical Affairs, CMC) to ensure program milestones are met with budget and risks are proactively managed.
• Represent Clinical Operations in program-level meetings, regulatory interactions, and external collaborations.
• Lead the planning, initiation, execution, and close-out of complex Phase I oncology trials. Ensure all trial activities are conducted in accordance with the protocol, SOPs, GCP, and applicable regulations.
• Oversee the development and review of essential study documents (protocols, informed consent forms, CRFs, monitoring plans, study manuals) tailored to IND-enabling requirements.
• Manage and oversee external partners including CROs, central labs, safety vendors, eTMF providers, and others. Ensure deliverables are met on time, within budget, and to quality standards. Primary point of contact for vendor issue escalation and resolution.
• Participate in site selection, feasibility assessments, and initiation visits. Build strong relationships with vendors, investigators, and site staff to support efficient enrollment and high-quality data collection.
• Oversee the development and review of essential study documents such as protocols, informed consent forms, case report forms (CRFs), monitoring plans, and study manuals.
• Prepare and deliver study updates, metrics, and presentations to senior leadership. Represent Clinical Operations in internal and external meetings.
• Establish and grow the Clinical Operations team over time, fostering a culture of high performance and continuous improvement.
• Manage, mentor, and support direct reports, fostering professional development and team performance.
• Review monitoring reports and ensure timely resolution of issues. Provide guidance to CRO monitors and ensure appropriate sponsor oversight is documented.
• Collaborate with finance and legal teams to manage study budgets, review vendor invoices, and negotiate contracts and change orders.
• Work closely with internal stakeholders including Clinical Development, Regulatory Affairs, Medical Affairs, and CMC to ensure alignment and smooth execution of clinical programs.
• Contribute to the development and implementation of SOPs, work instructions, and operational plans to enhance team efficiency and compliance.
• Perform periodic oversight visits of sites and/or vendors to assess progress and compliance.
• Other activities as assigned.

Qualifications

• Bachelor‚Äôs degree in life sciences or related field.
• Minimum of 10‚Äì14 years of total experience in clinical research, including at least 6-8 years in clinical trial management.
• Demonstrated experience managing IND-enabling or early-phase oncology trials, particularly in solid tumors, immunotherapy, and/or biologics.
• Proven track record of leading trials from start-up through close-out, including protocol development, site initiation, vendor selection/management, and data review.
• Strong knowledge of ICH GCP, FDA regulations, and global clinical research guidelines (including EU and APAC).
• Strong IT skills in MS Office and clinical trial systems (e.g., CTMS, eTMF, EDC).
• Ability to interpret and analyze clinical data and metrics.
• 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.
• Ability to travel up to 15%.