Associate Director, Supply Chain, Logistics

🕒 il y a 1 mois

🏄 California – Distant

infoinfo

💵 $180 500 - $199 500 / an

⏰ Temps Plein

🟠 Senior

🔗 Responsable Supply Chain

🗣️🇺🇸🇬🇧 Anglais requis

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Repérée par Remote Rocketship il y a 1 mois

Toujours ouverte sur le site de Atrium Therapeutics. Vérifiée il y a 4 heures.

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Atrium Therapeutics

11 - 50 employés

Fondée en 2026

🧬 Biotechnologie

💊 Pharmaceutique

Biotechnology • Pharmaceuticals

Atrium Therapeutics est une entreprise de biotechnologie en phase clinique développant des médicaments à ARN de précision ciblés sur le cœur. La société dispose d'une plateforme propriétaire de livraison d'ARN, basée sur la technologie AOC (conjugué anticorps-oligonucléotides) cliniquement validée, initialement conçue chez Avidity Biosciences, permettant l'administration de thérapies à base d'oligonucléotides directement dans le muscle cardiaque tout en traitant les limitations liées à la cytotoxicité, l'immunogénicité et le redosage. Le portefeuille d'Atrium comprend des candidats principaux comme l'ATR-1072 pour le syndrome PRKAG2 et l'ATR-1086 pour la cardiomyopathie PLN, ainsi que d'autres cibles en phase de recherche dans les cardiomyopathies rares ; la société prévoit de déposer une demande d'IND pour l'ATR-1072 au second semestre 2026. Atrium se positionne en pionnière de la cardiologie de précision en apportant des thérapeutiques à ARN aux patients atteints de maladies cardiaques génétiques et rares.

Description

• Provide strategic direction for clinical supply strategies and create actionable clinical supply plans • Manage IRT/RTSM vendors, specification gathering, user acceptance testing, and IRT lifecycle • Ensure accurate randomization, resupply, and inventory levels across studies and sites • Identify and mitigate clinical supply risks and build contingency plans • Align clinical supply timelines with study start-up, enrollment, and closeout milestones • Oversee packaging, labeling, distribution, and return drug management with CMOs • Represent Clinical Supply Chain in cross-functional study team, CRO, and vendor meetings • Author pharmacy manuals and participate in study-document reviews • Own shipping and logistics requests for GMP and non-GMP materials across technical and scientific teams • Manage couriers, freight forwarders, and specialty cold-chain carriers • Own import/export compliance, licenses, permits, customs documentation, and country-specific import requirements • Oversee cold-chain shipment execution, packaging qualification, temperature excursion investigations, and corrective actions • Monitor shipment status, coordinate inbound/outbound logistics, resolve delays or exceptions, and maintain tracking/reporting • Ensure compliance with GMP, GCP, and applicable import/export regulations • Maintain inspection-ready documentation and file records in eTMF/quality systems • Support SOP creation and revision • Lead or contribute to deviation, CAPA, and investigation processes related to supply or shipping issues

🎯 Exigences

• 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 • Direct experience in packaging, labeling, and distribution of investigational products through all stages of international clinical studies • 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 • Role based in San Diego, CA or remote

🏖️ Avantages

• Stock options & RSUs • 401(k) with employer match • Medical coverage • Dental coverage • Vision coverage • LTD coverage • Unlimited time off, including summer & winter breaks • Learning and development programming • Job-specific industry training opportunities • Education reimbursement program

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