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Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- 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
Requirements
What you’ll need- 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
Benefits
Comp & perks- Remote work environment
- Equal employment opportunities and protection from discrimination and harassment