Senior Clinical Trial Manager

Janux Therapeutics

Senior Clinical Trial Manager leading Phase I oncology trials at Janux Therapeutics, a biotech company. Overseeing CROs, vendors, clinical sites, regulatory compliance, budgets, and cross-functional execution.

Posted 8/5/2026full-timeSan Diego • California • 🇺🇸 United StatesSenior💰 $165,000 - $180,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in managing complex Phase I oncology trials, ensuring compliance with GCP, FDA, and ICH regulations while leading cross-functional teams and overseeing external partners. Capable of maintaining inspection readiness and providing mentorship to junior team members.

Highest-signal resume keywords

Oncology Trial ManagementRegulatory ComplianceCross-Functional Team LeadershipCRO OversightClinical Trial Processes

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial ManagementProtocol DevelopmentData ReviewIssue ResolutionBudget Management

Soft Skills

MentorshipRelationship BuildingCollaborationCommunication

Tools & Technologies

ETMFCRFsMonitoring Plans

Industry Keywords

GCPFDAICHBiotechPhase I Trials

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Lead the planning, initiation, execution, and close-out of complex Phase I oncology trials.
Ensure trial activities comply with protocols, SOPs, GCP, and applicable regulations.
Manage and oversee CROs, central labs, biometrics, safety vendors, eTMF providers, and other external partners.
Manage, mentor, and support direct reports.
Participate in site selection, feasibility assessments, and initiation visits.
Build relationships with investigators and site staff to support enrollment and data collection.
Oversee development and review of protocols, informed consent forms, CRFs, monitoring plans, and study manuals.
Review monitoring reports and ensure timely issue resolution and documented sponsor oversight.
Conduct ongoing data reviews and support data cleaning.
Maintain inspection readiness, including regular Trial Master File review.
Collaborate with finance and legal teams on budgets, invoices, contracts, and change orders.
Collaborate with Clinical Development, Data Management, Regulatory Affairs, Medical Affairs, and CMC.
Provide guidance and mentorship to junior team members and cross-functional colleagues.
Prepare study updates, metrics, and presentations for senior leadership.
Represent Clinical Operations in internal and external meetings.
Contribute to SOPs, work instructions, and operational tools.
Travel up to 15% for site visits, vendor meetings, and conferences.

Requirements

What you’ll need

Deep understanding of clinical trial processes.
Knowledge of regulatory compliance, including GCP, FDA, and ICH requirements.
Experience managing early-phase oncology trials at a sponsor biotech.
Ability to lead cross-functional teams.
Ability to oversee CROs, vendors, and clinical sites across U.S. and international regions.
Ability to ensure high-quality, timely, and cost-effective trial execution.
Willingness to travel up to 15%.

Benefits

Comp & perks

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
Restricted stock units
Stock purchase plan (ESPP)
Target bonus
Comprehensive benefits package for employees and their families
Supplemental disability insurance