I am recruiting for a Global Drug Supply Manager position for a multinational pharmaceutical company, they are a European leader and one of the largest globally in their field.
Provides guidance and oversight to internal and external project team members for the successful management of all aspects of study operation management in accordance with GCP/ICH Guidelines, applicable regulatory requirements, company SOPs, and study protocols. Participates in the management of budgets and timelines, as well as the preparation of clinical status reports, along with the Program Leader's Supervision.
Main Responsibilities for role:
- The Global Drug Supply Manager provides guidance and oversight to internal and external global Clinical Trial Material (CTM) staff for supply strategy of products for businesses clinical studies. This position is a strategically focused one as CTM Team Lead for all products / clinical trials within the portfolio as well as individual contributor responsibility for assigned clinical studies.
- Lead a functional group of 4 direct reports
- Work cross functionally with both internal and external teams including: Regulatory, Quality, R&D, Project Management, Finance, Manufacturing, Packaging/Labelling, Supply Chain, CTM vendors, IWRS vendors, investigator site staff (investigators, study coordinators) and CRO staff
- Oversight and development of study specific timelines for drug shipment set-up, including management and mitigation of deliverables for trials
- Contribution to the identification of risks and opportunities (including contingency and mitigation plans) for the clinical risks and opportunities registry
- Oversee and develops the short-term and long-range forecasting of clinical study drug, placebo and ancillary supply needs for various protocol designs.
- Collaborates with project team to complete and document User Acceptance Testing for Interactive Response Technology (IRT) systems.
- May participate in bid defence meetings for new business opportunities to articulate capabilities of the CTSM team and proposed strategies for management of clinical trial supplies logistics
- Contact with internal and external stakeholders to ensure on-time manufacture and delivery of products
- Participates in vendor selection and contributes to the RFP process for IRT/IVRS and global drug shipment
- Provide oversight/ensures the development of specifications for IVRS/IWRS systems for randomization and drug supply management and/or development of complex models for manual drug supply management throughout trial lifecycle
- Drafts, reviews and approves relevant documents, including informed consent, site worksheets, vendor site manuals (pharmacy, lab), monitoring reports
Your knowledge and experience:
- Ideally 8 plus years' experience within Clinical/Pharmaceutical Drug Supply
- Understanding of global regulations and requirements
- Line management experience
- Experience gained within Sponsor/Biotech/Pharma preferable
If you are interested in this Global Drug Supply Manager's position please contact me through LinkedIn or directly to arrange a confidential follow up call: 01 645 5222, Mobile: 087 621 4254, email@example.com