Job Summary:
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.
Job 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).
Education & 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.
• Experience in rare disease, cardiology, or genetic medicine clinical trials is a plus.
• 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.
• Some domestic and/or international travel may be required to support vendor, depot, or CMO site visits.
• This role is based in San Diego, CA or Remote
What We Provide:
• The base salary range for this role is $180,500-$199,500. The final compensation will be commensurate with such factors as relevant experience, skillset, internal equity and market factors.
• Atrium offers competitive compensation and benefits which include stock options & RSUs, as well as a 401(k) with an employer match. In addition, the comprehensive wellness program includes coverage for medical, dental, vision, LTD, and unlimited of time off including summer & winter breaks.
• A commitment to learning and development which includes a variety of programming internally developed by and for Atrium employees, opportunities for job-specific training offered by industry, and an education reimbursement program.
$180,500 - $199,500 biweekly
