Sr. Clinical Trial Manager

Janux Therapeutics; San Diego (CA); On-site; USD 175,000 - 200,000; Full time

Benefits offered by this job

Annual bonus program

Stock options

401k plan with employer contributions

Medical insurance (comprehensive)

Dental insurance

Vision insurance

HSA/FSA and supplemental coverages

Unlimited PTO

Relocation assistance

Job summary

Janux Therapeutics is seeking an Associate Director, Clinical Operations to manage operational aspects of early-phase oncology trials across the U.S. and international sites.

You will oversee CROs, vendors, and sites, ensure GCP compliance, and lead cross-functional teams to deliver high-quality, timely trial execution. The role requires strong trial management experience in sponsor biotech environments, with a focus on early-phase oncology.

Responsibilities

• Lead the planning, initiation, execution, and close-out of Phase I oncology trials in accordance with protocol, SOPs, GCP, and regulations.
• Oversee external partners including CROs, central labs, biometrics, safety vendors, and eTMF providers to meet deliverables on time, within budget, and to quality standards.
• Provide mentorship and support to direct reports, fostering development and performance.
• Participate in site selection, feasibility, and initiation visits; build strong relationships with investigators and site staff for enrollment and data quality.
• Develop and review study documents such as protocols, informed consent forms, CRFs, monitoring plans, and manuals.
• Review monitoring reports and guide CRO monitors, ensuring sponsor oversight.
• Conduct ongoing data reviews and support data cleaning; maintain TMF inspection readiness.
• Collaborate with finance and legal teams to manage study budgets, invoices, and contracts.
• Coordinate with Clinical Development, Data Management, Regulatory Affairs, Medical Affairs, and CMC to align programs.
• Provide guidance to junior staff and cross-functional colleagues; share best practices and drive process improvements.
• Prepare and present study updates, metrics, and senior leadership materials; represent Clinical Operations in meetings.
• Contribute to SOPs, work instructions, and operational tools to boost efficiency and compliance.
• Willingness to travel up to 15% for site visits and conferences.

Job description

The Associate Director, Clinical Operations will be responsible for managing operational aspects of assigned clinical trials, with a focus on early-phase oncology studies. This includes oversight of contract research organizations (CROs), vendors, and clinical sites across both U.S. and international regions. The role 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. The ideal candidate will bring an in-depth understanding of managing early phase oncology trials at a sponsor biotech.

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES

• 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.
• Manage and oversee external partners including CROs, central labs, biometrics, safety vendors, eTMF providers, and others. Ensure deliverables are met on time, within budget, and to quality standards.
• Manage, mentor, and support direct reports, fostering professional development and team performance.
• Participate in site selection, feasibility assessments, and initiation visits. Build strong relationships with 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.
• Review monitoring reports and ensure timely resolution of issues. Provide guidance to CRO monitors and ensure appropriate sponsor oversight is documented.
• Conduct ongoing data reviews and support data cleaning activities. Ensure inspection readiness at all times, including regular review of the Trial Master File (TMF).
• 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, Data Management, Regulatory Affairs, Medical Affairs, and CMC to ensure alignment and smooth execution of clinical programs.
• Provide guidance and mentorship to junior team members and cross-functional colleagues. Share best practices and contribute to continuous process improvement.
• Prepare and deliver study updates, metrics, and presentations to senior leadership. Represent Clinical Operations in internal and external meetings.
• Contribute to the development and implementation of SOPs, work instructions, and operational tools to enhance team efficiency and compliance.
• Willingness to travel up to 15% for site visits, vendor meetings, and conferences.
• Other activities as assigned.

$175,000 - $200,000 a year

In addition to a competitive base salary ranging from $175,000 to $200,000, we offer stock options, restricted stock units, a stock purchase plan (ESPP) and a target bonus. Janux also provides a comprehensive benefits package for our employees and their families, which includes medical, dental, vision, and supplemental disability insurance. Relocation assistance may also be available.

Please note that the base salary range is a guideline, and individual total compensation will vary based on factors such as qualifications, skill level, competencies, internal equity, and work location.

Job Type

• Full-time

Benefits

• Annual bonus program
• Incentive stock option plan
• 401k plan with flat non-elective employer contribution
• Comprehensive medical insurance with 90-100% employer-paid premiums
• Dental and vision insurance
• HSA, FSA, and supplemental insurance plans (life, disability, accident, critical illness, hospital indemnity)
• Unlimited PTO
• Generous holiday schedule; includes summer and winter company shutdown
• Relocation assistance

Schedule

• Monday to Friday

Work authorization

• United States (Required)

Additional Compensation

• Annual targeted bonus %

Work Location

• On site (San Diego, CA)

EQUAL OPPORTUNITY EMPLOYER

Janux Therapeutics, Inc. is an equal opportunity employer that is committed to providing a work environment free of harassment and discrimination based upon a protected category, as well as an environment free from retaliation for protected activity.