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Janux Therapeutics · 2 weeks ago

Sr. CTM/Associate Director, Clinical Operations

San Diego County, CA

Full-time

Onsite

Senior Level, Lead/Staff, Director/Executive

$205K/yr - $235K/yr

8+ years exp

Janux Therapeutics is focused on advancing innovative therapies in oncology, and they are seeking a Sr. CTM/Associate Director of Clinical Operations. This role involves managing operational aspects of clinical trials, particularly early-phase oncology studies, ensuring compliance and quality throughout the trial process.

BiotechnologyHealth DiagnosticsPharmaceuticalTherapeutics

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, 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

Qualification

Clinical trial managementOncology trials experienceRegulatory compliance knowledgeMS Office proficiencyClinical trial systemsLeadership skillsCommunication skillsOrganizational skillsTime managementAttention to detail

Required

BA/BS in related scientific field with a minimum of 8-10 years (Sr. CTM) OR 10–12 years (Associate Director) of experience in clinical research, with at least 6 years in clinical trial management

Demonstrated experience managing early-phase oncology trials, particularly in solid tumors and immunotherapy/biologics

Proven track record of leading trials from start-up through close-out, including protocol development, site initiation, vendor management, and data review

Strong knowledge of ICH GCP, FDA regulations, and global clinical research guidelines

Proficiency 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

Strong organizational and time management abilities

High level of accountability, adaptability, and attention to detail

Ability to work independently and collaboratively in a fast-paced, matrixed environment

Ability to travel up to 15%