Director, Global Clinical Supply — Remote Packaging & Logistics

Pulmovant

United States

On-site

USD 150,000 - 210,000

Full time

5 days ago
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Job summary

Pulmovant is seeking a Director of Clinical Supply to lead planning and execution of global clinical supply chains for its PH-ILD program. You will oversee packaging, labeling, and distribution of IMP, manage inventory, forecasting, and vendor performance, and collaborate across CMC, Clinical Operations, QA and Regulatory to ensure cGMP compliance.

The role demands extensive experience in global clinical supply management, with a focus on developing efficient supply processes and maintaining

Qualifications

  • Minimum 8 years of pharma experience with 5+ years in global clinical supply management.
  • Investigational drug product experience and GCP training required.
  • Experience with clinical supplies or operations is preferred.

Responsibilities

  • Oversee packaging, labeling, and distribution of IMP for global trials.
  • Mentor and manage Clinical Supply Managers and vendors (CMOs).
  • Develop kits/labels for multiple regions and support IND filings.
  • Establish SOPs for packaging and distribution to meet cGxP requirements.
  • Develop pharmacy manuals with internal SMEs and ensure regulatory readiness.
  • Lead vendor selection for clinical study support and CMO qualification.
  • Serve as the SME for clinical supply in regulatory inspections.
  • Proactively address risk and implement business continuity plans.
  • Coordinate with CMC, Clinical Ops, QA and Regulatory teams.

Skills

Global Clinical Supply
Vendor management
Forecasting
cGMP / cGxP
IVRS/IWRS systems
Regulatory knowledge
Project management
Stakeholder collaboration
Inventory management
IND filings support

Education

Bachelor's degree in Life Sciences
GCP training

Tools

IVRS/IWRS
Excel
PowerPoint
MS Project

Job description

Pulmovant is seeking a Director of Clinical Supply to lead planning and execution of global clinical supply chains for its PH-ILD program. You will oversee packaging, labeling, and distribution of IMP, manage inventory, forecasting, and vendor performance, and collaborate across CMC, Clinical Operations, QA and Regulatory to ensure cGMP compliance.

The role demands extensive experience in global clinical supply management, with a focus on developing efficient supply processes and maintaining

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