Senior Manager, Clinical Supply Chain

Janux Therapeutics Inc.•San Diego, CA

44d•Onsite

About The Position

The Senior Manager 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 Director of Supply Chain, this role will also collaborate with other functions within CMC, Clinical Operations, Regulatory and Quality Assurance (QA) to forecast and support clinical trial supply requirements including clinical drug manufacturing schedules and inventory, packaging, labeling, and distribution activities.

Requirements

Bachelor's degree in a scientific or pharmaceutical discipline.
6+ years of biotechnology/pharmaceutical industry experience with direct experience in clinical supply chain management.
Inventory management and vendor oversight experience in all phases of drug development for biologics with global clinical supply distribution is required.
Strong knowledge of cGMP, GCP regulations, and Annex 13 and VI.
Solid understanding of clinical research protocol requirements and experience developing IRT specifications.
Experience with logistic systems and shipping required.
Effective communication and direction.
Ability to identify project risks and rapidly develop and implement risk mitigation strategies in a fast-paced environment with changing priorities.

Nice To Haves

Familiarity with biologics manufacturing processes is highly desirable.

Responsibilities

Prepare, maintain, and periodically re-evaluate demand forecasts and supply strategies to ensure uninterrupted IMP supply to clinical sites while minimizing product waste throughout the clinical trial.
Contribute to and review Interactive Response Technologies (IRT) specifications; manage IRT systems in alignment with the overall supply strategy.
Collaborate with cross-functional teams to create and approve labeling designs in compliance with regulatory requirements.
Manage packaging activities at the Clinical Packaging Organization (CPO) and coordinate with QA for release.
Contribute to the preparation and review of clinical trial pharmacy manuals and packaging batch records.
Oversee distribution and inventory of clinical trial material across depots and sites.
Manage drug return, destruction process, and accountability at the depots.
Coordinate material shipments from CDMO to storage facilities and CPOs.
Review and approve third-party vendor invoices, ensuring accuracy and compliance with contractual terms.
Partner with QA on quality events, investigations, deviations/CAPA, batch record review and drug disposition.
Manage expiry date extensions, documentation, and related distribution activities.
Participate in forecast meetings with Clinical Operations. Prepare presentation materials and communicate inventory updates and operational strategies.
Identify and lead process improvement initiatives to enhance efficiency and compliance.
Perform other responsibilities as assigned.