Associate Director, Clinical Supply Chain & Logistics
亚特里奥是一个生物制药公司，先驱地向心脏提供 RNA 治疗，以改变患有心肌病的人的护理标准。我们的专利技术利用 Avidity 最初设计的针对性 RNA 递送平台，该平台结合了 mAbs 和其他针对性的输出联的组织选择性和寡核突素的精度。这种独特组合旨在允许对以前无法药物化的疾病基因驱动因素进行选择性目标定位。通过针对性非病毒性传递 siRNA 到心脏组织，我们的方法有潜力克服非特定的病毒和纳米粒子基础的输送系统的主要限制，包括与组织特异性，免疫原生性和重剂相关的挑战。工作简介：阿里奥治疗公司正在寻找一个经验丰富的临床供应链和物流副主任来管理阿里奥的心血管病理计划的端到端规划，执行和监督临床试验材料供应。该职位包括临床供应预测，包装和标签，IRT/RTSM 配置，仓库供应商管理和分销，并扩展范围，包括运输和物流业务的责任，包括运营商和货运人管理，进口/出口和海关合规，冷链运输协调和执行阿特里奥技术运营和其他团队。该角色与临床运营，质量，技术运营，监管和外部 CMO/3PL 合作伙伴密切合作，以确保无间断，符合和及时的药品供应。雇佣水平 （高级经理对抗）副主任) 将根据选定的候选人的经验确定。工作责任：•通过将试验设计，招生假设，制造准备和监管要求转化并集成到可操作的临床供应计划中，为临床供给战略提供战略方向。•在整个研究期间管理 IRT/RTSM 供应商和主要规范收集，用户接受性测试和 IRT 生命周期，确保精确的随机定向，补充和库存水平。•确定和减轻临床供应风险 （例如，过期期，需求变化，单源依赖性）并制定防务计划以防止试验中断。•与临床运营，CMC,监管事务和质量合作，协调临床供给时间表
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Atrium is a biopharmaceutical company pioneering delivery of RNA therapeutics to the heart to transform the standard of care for people living with cardiomyopathies. Our proprietary technology leverages the targeted RNA delivery platform initially designed at Avidity, which combines the tissue selectivity of mAbs and other targeted delivery ligands with the precision of oligonucleotides.
This unique combination is designed to allow selective targeting of the underlying genetic drivers of disease that were previously undruggable. Through targeted, non-viral delivery of siRNA to cardiac tissues, our approach has the potential to overcome key limitations of nonspecific viral and nanoparticle-based delivery systems, including challenges related to tissue specificity, immunogenicity, and redosing.
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.