Senior Manager, Clinical Supply
New
P
PulmovantBiotechnology
Remote, US, Maintain general availability during standard business hoursFull-TimeManager
Salary not disclosed
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Job Details
- Experience
- Minimum of 5 years of related experience in the pharmaceutical industry with at least 2 years of direct experience in Global Clinical Supply Management.
- Required Skills
- GCPMicrosoft Excel
Requirements
- Minimum 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 (Good Clinical Practice) training.
- Thorough knowledge of cGMP, ICH/cGxP guidelines, and global Health Authority requirements.
- Demonstrated experience with global clinical supply forecasting, planning, packaging, and labeling.
- Experience with inventory management and IVRS/IWRS systems.
- Understanding of clinical trial designs (randomized, double-blind, placebo-controlled).
- Proficiency in IVRS/IWRS, Excel, PowerPoint, and MS Project.
- Strong organizational, project management, and communication skills.
- Ability to work effectively under pressure.
Responsibilities
- Support all clinical supply activities for on-going and new clinical trials including demand forecasting, pharmacy manual drafting, and distribution.
- Coordinate with Clinical Operations, CROs, and sites to support enrollment and ongoing participant dosing.
- Manage contract manufacturing, packaging, labeling, and international shipping of investigational products to ensure on-time delivery.
- Partner with CMC, Clinical Operations, QA, and Regulatory teams to develop kits and label text for global regions.
- Participate in and lead IXRS development and system maintenance.
- Develop risk mitigation plans to proactively identify potential supply issues and ensure inspection readiness.
- Support vendor selection and qualification for clinical packaging and labeling facilities.
- Coordinate with CMC regarding global movement of materials to support drug development.
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