Associate Director, Supply Chain & Logistics

Atrium Therapeutics•San Diego, CA

1d•Remote

About The Position

Atrium Therapeutics is seeking an experienced Associate Director, Clinical Supply Chain & Logistics to manage the end-to-end planning, execution, and oversight of clinical trial material supply for Atrium's cardiomyopathy programs. This role owns clinical supply forecasting, packaging and labeling, IRT/RTSM configuration, depot vendor management and distribution, and has an expanded scope to include responsibility for shipping and logistics operations — including carrier and freight-forwarder management, import/export and customs compliance, cold-chain shipment coordination and execution for Atrium Technical Operations and other teams. The role partners closely with Clinical Operations, Quality, Technical Operation, Regulatory, and external CMO/3PL partners to ensure uninterrupted, compliant, and on-time drug supply. Level of hire (Senior Manager vs. Associate Director) will be determined based on the selected candidate's experience.

Requirements

Bachelor's degree in life sciences, supply chain, logistics, or a related field required; advanced degree preferred.
Associate Director: typically 10+ years, of clinical supply chain experience in biotech/pharma, with direct experience in packaging, labeling, and distribution of investigational products through all stages of international clinical studies (start-up, enrollment, maintenance and close-out)
Demonstrated experience managing shipping, logistics, or distribution operations, including carrier/freight-forwarder management and import/export or customs compliance.
Experience with IRT/RTSM systems, clinical supply forecasting tools, and CMO/depot network management.
Working knowledge of GMP, GCP, and global import/export regulations relevant to clinical trial materials.
Strong vendor management, negotiation, and cross-functional collaboration skills.
Ability to manage multiple competing priorities in a fast-paced, growing biotech environment.
Excellent analytical, organizational, and written/verbal communication skills.
Comfort operating with the autonomy and hands-on scope typical of a small, growing company.

Nice To Haves

Experience in rare disease, cardiology, or genetic medicine clinical trials is a plus.
Some domestic and/or international travel may be required to support vendor, depot, or CMO site visits.

Responsibilities

Provide strategic direction for clinical supply strategies by translating and integrating trial designs, enrollment assumptions, manufacturing readiness and regulatory requirements into actionable clinical supply plans.
Manage IRT/RTSM vendor and lead specification gathering, user acceptance testing and IRT lifecycle throughout study duration, ensuring accurate randomization, resupply, and inventory levels across studies and sites.
Identify and mitigate clinical supply risks (e.g., expiry, demand variability, single-source dependencies) and build contingency plans to prevent trial disruptions.
Partner with Clinical Operations, CMC, Regulatory Affairs, and Quality to align clinical supply timelines with study start-up, enrollment, and closeout milestones.
Oversee and coordinate packaging, labeling (including label design and label proof development), distribution and return drug management activities with CMOs according to approved budgets and plans.
Represent Clinical Supply Chain in cross-functional Clinical Study Team, CRO and vendor meetings.
Authors pharmacy manuals and participates in reviews of other study related documentation
Serve as the primary point of accountability for shipping and logistics requests across Technical Operations, Development Sciences, Biology and Chemistry teams, including transfers of GMP and non-GMP materials (intermediates, drug substance, drug product, testing samples etc.)
Manage relationships with couriers, freight forwarders, and specialty cold-chain carriers
Own import/export compliance, including licenses, permits, customs documentation, and country-specific import requirements for material shipments.
Oversee cold-chain and temperature-controlled shipment execution, including packaging qualification, temperature excursion investigation, and corrective action.
Monitor shipment status end-to-end, coordinate with vendors on inbound/outbound logistics, proactively resolve delays or exceptions, and maintain shipment tracking and reporting for cross-functional stakeholders.
Ensure all clinical supply and logistics activities comply with GMP, GCP, and applicable import/export regulations.
Maintain inspection-ready documentation and ensure clinical supply and shipping records are filed appropriately in the eTMF/quality systems.
Support the creation and revision of SOPs related to clinical supply chain and logistics processes.
Lead or contribute to deviation, CAPA, and investigation processes related to supply or shipping issues (e.g., temperature excursions, shipment delays or damage).