Janux Therapeutics
Senior Director, Clinical Operations
San Diego, CA · Director · Full-time
Sponsorship not specified$245k-$260kDetected 78 days ago
GCPStakeholder ManagementBudgetingClinical TrialsClinical ResearchFDA RegulatoryResearchLeadershipCommunicationTime ManagementMentoringAdaptabilityMicrosoft Office
About the role
- The Senior Director of Clinical Operations will provide global operational leadership overseeing complex clinical programs focusing on innovative T-cell engager therapies for immunology and oncology indications.
- This role is responsible for efficient planning, resourcing and execution of portfolio level programs in adherence to ICH-GCP, FDA regulations, and company SOPs.
Responsibilities
- Drive global clinical operations strategy and execution for programs ensuring all clinical activities support IND-enabling -Phase 3 objectives, as well as future clinical development plans.
- Collaborate effectively cross-functionally with senior leadership to ensure operational initiatives support strategic company goals.
- Establish and refine scalable best practices to drive efficiency while preparing for future departmental growth.
- Oversee the development, review, and operational implementation of study documents, including protocols, informed consent forms, CRFs, monitoring plans, and pharmacy manuals ensuring consistency among programs.
- Responsible for successful external partner relationships including CROs, central labs, patient advocacy groups and others. Ensure deliverables are met on time, within budget, and to quality standards.
- Prepare and deliver program updates, establish KPIs and dashboards, and effectively present to all study teams. Strongly represent Clinical Operations in internal and external meetings.
- Mentor and support direct reports, fostering professional development, team performance and a strong culture.
- Develop and implement operational plans, timelines, and budgets for clinical programs.
Skills
- Strong experience in complex autoimmune indications, early phase experience strongly preferred.
- Ability to define strategy and ensure organizational goals are executed in global clinical operations plans.
- Proven track record of leading complex clinical programs from start to completion.
- Strong knowledge of ICH GCP, FDA regulations, and global clinical regulatory guidelines.
- Strong IT skills in MS Office and clinical trial systems (e.g., CTMS, eTMF, EDC).
- Expertise in clinical budgeting and efficient allocation of resources
- Strong organizational and time management abilities.
- Ability to work independently and collaboratively in a fast-paced, matrixed environment.
Compensation
- Annual targeted bonus %
Company info
- The Senior Director will report into the Vice President, Clinical Operations and will ensure strategic alignment of programs and key stakeholder management in a fast-paced environment, while mentoring and growing the Clinical Operations team and culture to ensure successful program delivery.
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.
- 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.
Visa & Work Authorization
- 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
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