Director, Clinical Supply

Job not on LinkedIn

🔥 0 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🔴 Lead

👨‍⚕️ Medical Director

👻 Ghost score 10%

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Pulmovant

WebsiteLinkedInAll Job Openings

11 - 50 employees

🏥 Healthcare

💼 Consulting

🍽️ 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.

📋 Description

• Provide planning and execution of Clinical Supply Chain activities to support global clinical studies • Coordinate clinical packaging, labeling, and distribution operations • Actively manage inventory, logistics, and forecasting for the clinical program • Serve as the subject matter expert for clinical drug supply throughout all phases of clinical trials • Support implementation of global clinical inventory management, supply planning, and distribution systems consistent with cGMP, clinical development programs, and corporate objectives • Manage vendor performance and performance metrics • Oversee contract manufacturing packaging, labeling, and international shipping/distribution operations for investigational medicinal product • Manage, coach, and mentor Clinical Supply Managers • Liaise with contract manufacturers and complete business and performance metrics • Work with CMC, Clinical Operations, QA, and Regulatory on kits, label text, and IND filing support • Establish SOPs, protocols, and procedures for clinical trial material packaging, labeling, and distribution in compliance with cGxP requirements • Manage pharmacy manual development • Manage vendor selection and work with Regulatory Compliance and QA on CMO selection and qualification • Serve as subject matter expert during regulatory inspections • Address risk management issues and implement business continuity plans

🎯 Requirements

• Minimum of 8 years of related experience in the pharmaceutical industry • At least 5 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 • Ability to communicate and maintain collaborative relationships effectively with key internal and external stakeholders • Proven ability to select, secure and manage external vendors to achieve results and control expenditures • 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 computer software applicable to IVRS/IWRS, Excel, PowerPoint and MS Project • Good organizational, communication and presentation skills, effective project and time management skills, and the ability to work under pressure • Experience with regulatory submissions is a plus • Ability to use a computer, communicate via phone, video and electronic messaging, solve problems, collaborate with others, and maintain general availability during standard business hours

🏖️ Benefits

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