Senior Manager, Clinical Supply

🕒 Outubro 14

❄️ Minnesota – Remoto

❄️ Minnesota – Remote

💵 $160.000 - $175.000 / ano

⏰ Tempo Integral

🟠 Sênior

👔 Gerente

👻 Score fantasma 2%

O que significa: a chance de ninguém estar realmente contratando para esta vaga.Como ler: 60% ou mais significa que achamos que é uma vaga fantasma. Pontuações mais baixas preocupam menos.Por que essa pontuação:

• Aberta há 28 dias.
• As vagas desta empresa costumam ser preenchidas em 45 dias.

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Celcuity

SiteLinkedInTodas as Vagas

51 - 200 funcionários

🏥 Saúde

🧬 Biotecnologia

💊 Farmacêutico

Healthcare • Biotechnology • Pharmaceuticals

A Celcuity é uma empresa de biotecnologia em estágio clínico desenvolvendo terapias direcionadas que bloqueiam a via PI3K/AKT/mTOR (PAM) para tratar múltiplos tumores sólidos. Seu principal candidato, gedatolisib, é um inibidor potencial inédito pan-PI3K e mTORC1/2, sendo avaliado em ensaios clínicos para câncer de mama e próstata. A empresa avança com um pipeline focado em fornecer tratamentos oncológicos transformadores e direcionados, conduzindo desenvolvimento clínico e pesquisa orientada por dados para apoiar a adoção regulatória e médica.

Descrição

• 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

🎯 Requisitos

• 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

🏖️ Benefícios

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

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