The Associate Director of Supply Chain will be responsible for the strategic operational oversight of all aspects of clinical supply chain to ensure timely drug supply for Janux’s clinical programs. Reporting into the Vice President of CMC, this role will also collaborate with other functions within CMC, Clinical Operations, Regulatory and Quality Assurance to forecast and support clinical trial supply requirements including clinical drug manufacturing schedules and inventory, including packaging, labeling and distribution activities.
ESSENTIAL FUNCTIONS AND RESPONSIBILITIESDevelop and implement clinical supply strategies and oversee distribution and inventory of clinical trial material to ensure uninterrupted IMP supply to clinical sites and minimize product waste throughout the duration of the clinical trial.Provide strategic direction for clinical supply planning to establish IRT system requirements IRT system specifications and contribute to the cross-functional review and approval of IRT user acceptance testing (UAT).Develop and manage forecasts and inventory strategies; analyze actual spend against projections to support accurate budget forecasting and ensure operations remain within financial targetsCollaborate with cross-functional departments to create and approve labeling designs in alignment with regulatory framework.Manage packaging activities at CPO and collaborate with QA team for release.Contribute to the preparation and review of clinical trial pharmacy manuals and packaging batch records. Oversees distribution and inventory of clinical trial material.Manage drug return, destruction process, and accountability at the depots.Manage logistics and execution of material shipments from CDMOs to depots, testing facilities, and CPOs. Responsible for timely review and approval of third-party vendor invoices, ensuring accuracy, contractual compliance and alignment with financial controls.Collaborate with Quality Assurance team on Quality Events investigations, deviations/CAPA, Batch Record Review and drug disposition as required. Manage expiry date extensions, documentation, and distribution activities.Participate in forecast meetings with Clinical Operations including the preparation of slides and communication of inventory updates and operational strategies.Identify and lead process improvement initiatives.Other duties as deemed necessary.REQUIRED SKILLS AND QUALIFICATIONSBachelor’s degree in scientific or pharmaceutical discipline.8+ years of biotechnology/pharmaceutical industry experience with direct experience in clinical supply chain management.Inventory management and vendor oversight experience in Phase I-III clinical trials required. Global clinical supply distribution experience required.Experience using data visualization platforms or clinical supply software for management of operational logistics, inventory, and forecasting.Experience managing various products and sample shipping and receiving from and between CDMOs, CPOs, depots.Ability to evaluate clinical study assumptions and providing clinical supply forecasts to support manufacturing plans and budget endorsement.Demonstrated understanding of clinical research protocol requirements and experience developing IRT specifications.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:
· On site (San Diego, CA)
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.
Notice to Recruiters and Third-Party Agencies
The Talent Acquisition team manages the recruitment and employment process for Janux. To protect the interests of all parties involved, Janux will only accept resumes from a recruiter once a fully-executed search agreement is in place. Agencies are hereby specifically directed not to contact Janux employees directly in an attempt to present candidates. Janux will consider any candidate for whom an Agency and/or Recruiter has submitted an unsolicited resume to have been referred, free of any charges or fees.
