Manager, Clinical Supply

🔥 3 minutes ago

🇺🇸 United States – Remote

💵 $114k - $140k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

👔 Manager

👻 Ghost score 0%

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Secura Bio, Inc.

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2019

🏥 Healthcare

🏭 Manufacturing

🧬 Biotechnology

💰 $90M Debt Financing - Secura Bio on 2019-03

Healthcare • Manufacturing • Biotechnology

Secura Bio, Inc. is a commercial-stage biopharmaceutical company focused on developing, commercializing, and optimizing oncology therapies. The company emphasizes commercial strategy and market access for oncology medicines, supported by clinical development capabilities (clinical trials, expanded access, investigator-sponsored studies), medical education, and patient support programs. Headquartered in Berkeley Heights, New Jersey with an office in Dublin, Ireland, Secura Bio positions itself to maximize commercial outcomes for cancer treatments such as duvelisib.

📋 Description

• Lead end-to-end clinical supply planning and execution for assigned clinical programs • Develop and maintain clinical supply strategies covering forecasting, inventory planning, manufacturing, packaging, distribution, and contingency planning • Own clinical supply activities and ensure deliverables, milestones, and commitments are executed on time • Identify, communicate, and mitigate supply chain risks affecting study timelines, product availability, regulatory compliance, or operations • Liaise with Clinical Operations, Quality Assurance, Regulatory Affairs, Finance, contract manufacturers, packaging vendors, depots, and distribution partners • Oversee contract manufacturers, vendors, and logistics providers; drive issue resolution, accountability, and continuous improvement • Provide stakeholder status updates, issue escalation, and management reporting • Manage domestic and international clinical supply logistics and distribution in compliance with regulatory and quality requirements • Support budgeting, forecasting, inventory optimization, and strategic planning • Support Quality System activities including change controls, investigations, documentation, inspections, and continuous improvement

🎯 Requirements

• Bachelor's degree in Life Sciences, Supply Chain, Engineering, Business, or a related discipline, or equivalent combination of education and experience • Minimum five (5) years of experience in clinical supply chain, pharmaceutical manufacturing, CMC operations, or related pharmaceutical operations • Demonstrated experience developing and executing clinical supply strategies, including forecasting, inventory management, manufacturing planning, packaging, distribution, and vendor management • Strong knowledge of pharmaceutical manufacturing, clinical supply chain operations, cGMP requirements, GDP principles, and applicable regulatory requirements • Proven ability to independently manage multiple complex projects, drive execution of deliverables, and maintain accountability for results in a fast-paced environment • Demonstrated ability to proactively identify risks, develop mitigation strategies, and effectively communicate and escalate issues to stakeholders and management • Excellent communication, stakeholder management, and cross-functional leadership skills • Experience leading clinical supply operations for global Phase II and Phase III clinical studies • Experience working in a small or emerging biotechnology company environment • Experience managing external contract manufacturers, packaging vendors, depots, IRT providers, and global logistics partners • Knowledge of IRT/RTSM platforms, inventory management systems, serialization technologies, and clinical trial logistics processes • Ability to utilize digital tools, data analytics, automation, and artificial intelligence solutions • PMP, APICS/ASCM, Supply Chain, or related professional certification preferred