供应链与物流总监
Associate Director, Supply Chain & Logistics
Atrium是一家生物制药公司，致力于将RNA治疗药物递送至心脏，以改变心肌病患者的标准治疗方法。我们的专有技术利用了最初由Avidity设计的靶向RNA递送平台，该平台结合了单克隆抗体（mAbs）和其他靶向递送配体的组织选择性与寡核苷酸的精确性。
这种独特的组合旨在实现对之前无法成药的疾病潜在遗传驱动因素的选择性靶向。通过针对心脏组织的非病毒性siRNA递送，我们的方法有望克服非特异性病毒和纳米颗粒递送系统的重大局限性，包括与组织特异性、免疫原性和重复给药相关的挑战。
职位概述：
Atrium Therapeutics正在寻找一位经验丰富的高级经理，负责临床试验材料供应的全流程规划、执行和监督，涵盖Atrium的心肌病项目。该职位负责临床供应预测、包装和标签、IRT/RTSM配置、仓库供应商管理及配送，并扩展职责范围，包括负责运输和物流运营——包括承运商和货运代理管理、进出口及海关合规、冷链运输协调与执行，涉及Atrium技术运营及其他团队。该职位需要与临床运营、质量、技术运营、法规事务以及外部CMO/3PL合作伙伴紧密合作，确保药品供应不间断、合规且按时。招聘级别（高级经理或高级经理）将根据候选人的经验确定。
职位职责：
•通过将试验设计、入组假设、制造准备情况和监管要求转化为可执行的临床供应计划，为临床供应策略提供战略方向。
•管理IRT/RTSM供应商并主导规格收集、用户验收测试和IRT生命周期管理，确保研究期间随机化、补货和库存水平的准确性。
•识别并缓解临床供应风险（如过期、需求波动、单一来源依赖），并制定应急计划以防止试验中断。
•与临床运营、CMC、法规事务和质量部门合作，确保临床供应时间表一致。
查看英文原文
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.