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Janux Therapeutics

Clinical-stage biotech developing tumor-activated immunotherapies

Senior Director - Clinical Supply Chain

Clinical Research OperationsConfirmed live in the last 24 hours
Full-time

About the Job

Requirements

  • A bachelor's degree in life sciences, supply chain, or a related field is required.
  • At least 12 years of experience in biotech or pharmaceutical supply chain, including at least 4 years of people management experience within a clinical supply chain organization.
  • Strong experience supporting Phase 2 and Phase 3 clinical trials.
  • Experience supporting global clinical trials, including EU, APAC, and Canada, and multi-region labeling and distribution requirements.
  • Biologics experience is required.
  • Ability to operate hands-on within a small to mid-size biotech environment.
  • Expertise in clinical supply planning, forecasting, and inventory management.
  • Experience managing external vendors, including contract development and manufacturing organizations, depots, and logistics providers.
  • Working knowledge of interactive response technology systems and clinical supply infrastructure.
  • Understanding of Good Clinical Practice guidelines, 21 CFR, and Annex 13 requirements.
  • Ability to operate effectively in a fast-paced, evolving environment and navigate ambiguity.
  • Problem-solving skills focused on practical execution.
  • United States work authorization is required.

Responsibilities

  • Lead and develop clinical supply strategies across Phase 1–3 programs.
  • Ensure uninterrupted investigational medicinal product supply across global, multi-region clinical trials.
  • Lead end-to-end clinical supply operations, including packaging, labeling, distribution, returns, reconciliation, and destruction.
  • Provide strategy and support for global logistics, including import/export activities and depot strategy, while ensuring compliance with country-specific labeling and regulatory requirements.
  • Provide strategic leadership, cross-functional alignment, and operational oversight to ensure successful execution of key activities across Clinical Operations, Quality, Regulatory, and CMC functions.
  • Contribute to and review clinical trial documentation, including clinical protocols, pharmacy manuals, batch records, drug labels, and shipping documentation; oversee interactive response technology strategy, setup, and execution.
  • Partner with CMC to align manufacturing schedules with clinical supply needs and scale-up activities, and oversee comparator sourcing and supply strategies as needed.
  • Select, manage, and oversee external vendors, including contract development and manufacturing organizations, depots, packaging providers, and logistics providers; manage requests for proposals, statements of work, and vendor performance.
  • Partner with Quality Assurance on vendor qualification, audits, compliance activities, and development and maintenance of supply chain-related standard operating procedures and processes.
  • Ensure compliance with Good Clinical Practice and global regulatory requirements.
  • Support inspection readiness and regulatory submissions related to clinical supply.
  • Develop and manage clinical supply budgets, forecasts, and spend tracking.
  • Provide leadership with regular updates on supply status, risks, and planning assumptions.
  • Lead, mentor, and develop a small clinical supply team and build scalable processes to support company growth.

Desired Qualifications

  • Oncology therapeutic-area experience is strongly preferred.
  • Experience supporting the transition from early-stage to late-stage clinical development.
  • Experience building or scaling clinical supply chain functions in an emerging biotech environment.

About the Company

Janux Therapeutics

Clinical-stage biotech developing tumor-activated immunotherapies

Janux Therapeutics develops cancer immunotherapies that activate the immune system inside tumors to attack cancer while sparing healthy tissue. Its products are tumor-activated and use a proprietary platform masking technology to reduce toxic side effects and improve efficacy compared with traditional T cell engagers. The company advances drug candidates through clinical trials, aiming for regulatory approval and eventual commercialization, with revenue expected from partnerships, licensing, and the sale of approved therapies. Its lead program JANX007 is being evaluated in a Phase 1 trial (ENGAGER PSMA 01) for metastatic prostate cancer to assess safety and preliminary effectiveness.

Company size
51-200
Company stage
IPO
Headquarters
San Diego, CA
Founded
2017

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