Senior Manager, Clinical Supply

🕒 il y a 11 jours

❄️ Minnesota – Distant

❄️ Minnesota – Remote

💵 $160 000 - $175 000 / an

⏰ Temps Plein

🟠 Senior

👔 Manager

👻 Score fantôme 2%

Ce que ça veut dire : la probabilité que cette offre reste ouverte sans recrutement actif.Comment le lire : 60 % ou plus, on pense que c'est une offre fantôme. Un score plus bas est moins inquiétant.Comment on la calcule : ancienneté, republications, postes ouverts vs taille de l'équipe, rapidité de clôture, et si le salaire est indiqué.À noter : une estimation à partir de données publiques, pas un jugement sur l'entreprise. De vraies offres peuvent avoir un score élevé, alors prenez-le comme un indice, pas comme un fait.

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Celcuity

Site WebLinkedInTous les Emplois

51 - 200 employés

🏥 Santé

🧬 Biotechnologie

💊 Pharmaceutique

Healthcare • Biotechnology • Pharmaceuticals

Celcuity est une entreprise de biotechnologie en phase clinique développant des thérapies ciblées qui bloquent la voie PI3K/AKT/mTOR (PAM) pour traiter plusieurs tumeurs solides. Son principal candidat, le gedatolisib, est un inhibiteur potentiel de première classe pan-PI3K et mTORC1/2 en cours d'évaluation dans des essais sur le cancer du sein et de la prostate. L'entreprise avance un pipeline ciblé visant à offrir des traitements contre le cancer transformateurs et ciblés et mène un développement clinique et une recherche basée sur les données pour soutenir l'adoption réglementaire et médicale.

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

🎯 Exigences

• 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

🏖️ Avantages

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