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Senior Manager, Clinical Supply

šŸ”„ 13 hours ago

šŸ‡ŗšŸ‡ø United States – Remote

ā° Full Time

🟠 Senior

šŸ‘” Manager

šŸ‘» Ghost score 20%

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Logo of Pulmovant

Pulmovant

11 - 50 employees

šŸ„ Healthcare

šŸ’¼ Consulting

šŸ½ļø Food & Beverage

Healthcare • Consulting • Food & Beverage

Pulmovant is a company committed to transforming the lives of patients with pulmonary diseases by developing innovative therapies. Their lead product, mosliciguat, aims to provide a once-daily, inhaled treatment for pulmonary hypertension, distinguished by its novel sGC activation mechanism. With a singular focus on addressing the unique needs of patients suffering from pulmonary conditions, Pulmovant is engaged in extensive clinical trials to advance its pioneering treatment options.

šŸ“‹ Description

• Execute clinical supply chain activities supporting Pulmovant clinical studies globally • Coordinate clinical packaging, labeling, and distribution operations • Manage inventory and logistics for the clinical program • Serve as the subject matter expert for clinical drug supply throughout all clinical trial phases • Support implementation of global clinical inventory management, supply planning, and distribution systems • Manage vendors and performance metrics • Support clinical supply activities for ongoing and new clinical trials, including protocol demand forecasting, pharmacy manual drafting, trial monitoring, initial and resupply planning, and distribution • Coordinate with Clinical Operations, CROs, and sites to support enrollment and participant dosing • Coordinate contract manufacturing packaging, labeling, and international shipping/distribution of investigational medicinal product • Partner with CMC, Clinical Operations, QA, and Regulatory to develop kits and label text for multiple countries/regions • Lead or participate in IXRS development and system maintenance • Assist with risk mitigation plans and inspection-readiness process development • Support vendor selection and CMO qualification with Regulatory Compliance and QA • Coordinate global material logistics and movement with the CMC team

šŸŽÆ Requirements

• Minimum of 5 years of related experience in the pharmaceutical industry • At least 2 years of direct experience in Global Clinical Supply Management • Prior investigational drug product experience • Prior GCP training is required • Recent industry experience with clinical supplies or clinical operations is preferred • Demonstrated experience with global clinical supply forecasting, planning, packaging, labeling, inventory management, IVRS systems, and clinical trial designs (randomized, double-blind, placebo-controlled) • Thorough knowledge and understanding of cGMP, ICH/cGXP guidelines, and global Health Authority requirements • Proficiency in software applicable to IVRS/IWRS, Excel, PowerPoint, and MS Project • Good organizational, communication, and presentation skills • Effective project and time management skills • Ability to work under pressure • Ability to use a computer and communicate via phone, video, and electronic messaging • Ability to engage in problem solving, analysis, dialogue, collaboration, and maintain general availability during standard business hours

šŸ–ļø Benefits

• Remote work environment • Equal employment opportunities and protection from discrimination and harassment

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