Senior Manager, Clinical Supply

🕒 October 14

❄️ Minnesota – Remote

❄️ Minnesota – Remote

💵 $160k - $175k / year

⏰ Full Time

🟠 Senior

👔 Manager

👻 Ghost score 2%

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Celcuity

WebsiteLinkedInAll Job Openings

51 - 200 employees

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

Healthcare • Biotechnology • Pharmaceuticals

Celcuity is a clinical-stage biotechnology company developing targeted therapies that block the PI3K/AKT/mTOR (PAM) pathway to treat multiple solid tumors. Its lead candidate, gedatolisib, is a potential first-in-class pan-PI3K and mTORC1/2 inhibitor being evaluated in breast and prostate cancer trials. The company advances a focused pipeline aimed at delivering transformative, targeted cancer treatments and conducts clinical development and data-driven research to support regulatory and medical adoption.

📋 Description

• Develop and execute end-to-end clinical supply strategies for Phase I–III clinical studies • Create demand forecasts and supply plans based on study protocols, enrollment assumptions, and country-specific requirements • Determine proper use of materials as required by governing regulatory agencies • Perform risk assessments and mitigation planning • Optimize inventory and minimize waste • Manage packaging, labeling, distribution, returns, and destruction activities • Manage label text development • Coordinate global supply distribution • Monitor inventory levels • Ensure clinical trial materials have proper and complete documentation and correct and up-to-date information • Support vendor engagement activities, including contracts, meetings, invoices, and deliverables • Collaborate with Clinical Operations, Regulatory Affairs, Quality, and Pharmaceutical Development and Operations teams • Perform other duties as assigned

🎯 Requirements

• Bachelor’s degree in natural sciences, or related field; or relevant experience • 5+ years of experience in managing drug supply for global studies, or a related area • Knowledge of regulatory requirements with respect to clinical trial supplies • Excellent written and verbal communication skills, with ability to influence and build credibility at all levels • Strong interpersonal skills for interacting with employees and leaders across various levels and functions • Attention to detail and ability to manage multiple processes and documentation requirements • Strong technical and analytical skills with advanced knowledge in MS Office including Word, Excel, and PowerPoint • Experience with trial management software for randomization/supply required • Proficiency in depot management supporting shipments to sites • Expert knowledge of import/export regulations and requirements as it pertains to finished pharmaceuticals • Knowledge of tariffs, duties and VAT requirements, as appropriate • Ability to work in a team or independently as required • Outstanding organizational skills with the ability to prioritize • Demonstrated independent and sound decision-making skills; ability to think critically and make decisions in a fast-paced environment • Continuous improvement mindset; seeking ways to drive innovation and efficiencies throughout the organization • Flexible and willing to learn; adapting to business and site needs in a dynamic environment • Maintain a positive, approachable and professional attitude

🏖️ Benefits

• Annual performance incentive bonus • New hire equity package • Medical insurance • Dental insurance • Vision insurance • 401(k) match • PTO • Paid holidays

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