Vice President, Clinical Operations

Regulatory Toolkit; San Diego (CA); Hybrid; USD 260,000 - 420,000; Full time

Benefits offered by this job

Annual bonus program

Incentive stock option plan

401k with employer contribution

Comprehensive medical, dental, vision

HSA/FSA and supplemental insurance

Unlimited PTO

Relocation assistance

Job summary

Janux Therapeutics, Inc. is seeking a Vice President of Clinical Operations to lead the global clinical operations function, translating corporate priorities into integrated execution plans and building the capabilities to support portfolio growth across autoimmune indications.

The role partners with executive teams to ensure delivery of milestones from first-in-human through late-stage development, while maintaining sponsor oversight of CROs, vendors, budgets, and quality.

Qualifications

• Bachelor’s degree in life sciences or related discipline; 18+ years progressive clinical development and operations experience.

Responsibilities

• Own the global Clinical Operations vision, strategy, and operating model.
• Provide executive oversight of clinical programs from IND-enabling to later-stage development.
• Shape development strategy with cross-functional partners to executable clinical plans.
• Lead Portfolio governance, metrics, and escalation mechanisms for accountability.
• Oversee budgets, headcount, vendor commitments, and scenario planning; balance speed, quality, risk.
• Define scalable operations infrastructure, SOPs, and CGMP-compliant practices.
• Ensure sponsor oversight of CROs, central labs, and site strategies.

Skills

Strategic leadership

Executive stakeholder alignment

Clinical operations governance

Program management

Budgeting & forecasting

Vendor & CRO oversight

Risk management

Cross-functional collaboration

People leadership & development

Regulatory knowledge (ICH-GCP FDA)

Communication & presentation

Education

Bachelor’s degree in life sciences or related discipline

18+ years in clinical development and operations

Advanced scientific/medical/business degree preferred

Tools

CTMS

EDC

eTMF

Clinical trial vendor management tools

Job description

The Vice President of Clinical Operations will provide leadership for a clinical operations function and will be accountable for the operational strategy, execution, quality, and scalability of clinical programs supporting Janux’s innovative therapies across autoimmune indications. This executive will translate clinical development and corporate priorities into integrated operational plans, build the capabilities and organization required to support portfolio growth, and ensure delivery of clinical milestones from first-in-human development through late-stage execution. The Vice President will serve as a strategic partner to executive leadership and governance bodies, lead and develop a high-performing Clinical Operations organization, and maintain rigorous sponsor oversight of CROs, vendors, sites, timelines, budgets, quality, and risk.

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES

• Own the global Clinical Operations vision, functional strategy, and operating model, ensuring clinical execution is aligned with company objectives, portfolio priorities, and evolving development plans.
• Provide executive oversight of clinical programs from IND-enabling and first-in-human studies through later-stage development, ensuring integrated planning, disciplined execution, and readiness for future indications, geographies, and registrational pathways.
• Partner with Clinical Development, Clinical Science, Regulatory Affairs, Biometrics, Translational Sciences, Safety, CMC, Program Management, Finance, Legal, and Quality to shape development strategy and convert program objectives into executable clinical plans.
• Serve as the senior Clinical Operations representative to Executive Leadership and governance committees, providing clear recommendations on portfolio priorities, operational feasibility, risk, investment, resource allocation, timelines, and trade-offs.
• Establish portfolio-level governance, performance metrics, dashboards, and escalation mechanisms that enable proactive decision-making and consistent accountability across programs and studies.
• Lead long-range resource planning, organizational design, succession planning, and capability building for Clinical Operations; recruit, mentor, and retain leaders and teams capable of supporting a growing global portfolio.
• Create a high-performance, patient-focused culture grounded in accountability, collaboration, adaptability, operational excellence, and continuous improvement.
• Oversee clinical program budgets, forecasts, headcount plans, vendor commitments, and scenario planning; partner with Finance and executive leadership to balance speed, quality, risk, and capital efficiency.
• Define and maintain scalable clinical operations infrastructure, policies, SOPs, work instructions, systems, and standards that support inspection readiness, data integrity, and compliant global execution.
• Ensure robust sponsor oversight of CROs, central laboratories, clinical technology providers, specialty vendors, and other strategic partners, including governance, performance management, issue escalation, and relationship strategy.
• Provide executive oversight of site and country strategy, feasibility, enrollment planning, and investigator engagement; build durable relationships with investigators, key opinion leaders, advocacy organizations, and clinical research partners.
• Ensure the quality and operational consistency of protocols, informed consent forms, CRFs, monitoring plans, pharmacy manuals, study manuals, and other core clinical documents across the portfolio.
• Anticipate and manage program-level and portfolio-level operational risks, including enrollment, resourcing, vendor performance, quality, timelines, and budget; ensure mitigation and contingency plans are actionable and visible to leadership.
• Represent Clinical Operations in regulatory interactions, due diligence activities, external partnerships, and other business-critical forums as needed.
• Ensure all clinical activities are conducted in accordance with protocols, company SOPs, ICH-GCP, applicable FDA requirements, and relevant global regulations.

REQUIRED EDUCATION, EXPERIENCE, SKILLS, AND ABILITIES

• Bachelor’s degree in life sciences or a related discipline with 18+ years of progressive clinical development and operations experience in biotechnology or pharmaceutical organizations; advanced scientific, medical, or business degree preferred.
• Ability to fluidly shift between strategic leadership and operational problem-solving, representing Clinical Operations at the executive level while maintaining sufficient depth and expertise to directly support resolution of complex site, CRO, quality, enrollment, and study execution challenges.
• Demonstrated ability to anticipate, navigate, and adapt to unexpected obstacles, galvanizing executive leadership, cross-functional partners, and teams to address critical time-sensitive issues and keep programs on track.
• Demonstrated success overseeing a portfolio of complex global clinical programs, including early-phase development and progression toward later-stage or registrational execution.
• Strong experience in complex autoimmune indications; early phase and global experience strongly preferred.
• Experience advising Executive Leadership Teams and governance committees on clinical operations strategy, portfolio risk, resource allocation, budgets, timelines, and business trade-offs.
• Demonstrated success leading influence across Clinical Development, Clinical Science, Medical, Regulatory, Biometrics, Translational Sciences, Safety, CMC, Quality, Finance, Legal, and Program Management.
• Expert knowledge of ICH-GCP, FDA requirements, global clinical research regulations, inspection readiness, sponsor oversight obligations, and quality risk management.
• Deep expertise in CRO and vendor strategy, outsourcing models, governance, contracting, performance management, and escalation for complex global studies.
• Strong command of clinical budgeting, forecasting, resource modeling, portfolio planning, and capital-efficient decision-making.
• Experience designing scalable clinical operations processes, systems, metrics, and infrastructure, including CTMS, eTMF, EDC, and related clinical trial technologies.
• Exceptional executive presence, judgment, and communication skills, with the ability to present complex clinical, operational, financial, and risk information clearly to internal and external stakeholders.
• Demonstrated success attracting, developing, and retaining high-performing teams and creating an accountable, collaborative, and inclusive culture.
• Ability to operate effectively in a dynamic environment, set priorities across competing demands, make timely decisions with incomplete information, and maintain attention to quality and detail.
• Ability to travel up to 25% for leadership meetings, investigator engagement, vendor governance, site visits, and other business needs.

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:

• Hybrid preferred in San Diego office. Remote permitted upon approval, with ability to travel up to 25% for meetings or site visits as required.

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.