Manager, Clinical Supply Chain Mgmt

vor 5 Monaten

Zug, Schweiz Kiniksa Pharmaceuticals Vollzeit

This role is based in our Lexington office. Our office-based employees follow a hybrid schedule of 4 days in the office, and 1 day remote.

**Responsibilities **_(including, but not limited to)_**:

- Ensure continuous supply of clinical trial material for assigned studies globally
- Ensure on-time startup of new studies by having supplies available as required
- Manage clinical packaging and distribution vendors
- Design and execute packaging and labelling campaigns
- Support the procurement, labeling and distribution of comparators
- Review clinical protocols and design appropriate supply chain strategy
- Work collaboratively with Clinical Operations, Quality Assurance and Regulatory Affairs
- Interpretation of a protocol or study overview to calculate total demand and forecast over time
- Managing clinical labeling including label design, translation, and production
- Preparation of a supply plan to support the demand forecast, including determination of supply overage amounts and regular inventory update to project teams
- Manage international distribution and logistics for clinical programs, including importing and exporting clinical supplies globally
- Manage clinical packaging/distribution including negotiating contracts, designing clinical supply plans and developing the distribution instructions with clinical supply chain vendors
- Develop supply strategy to maximize supply efficiency, minimize waste while identifying risk and develop risk mitigation plans
- Work with the clinical team to configure and set up Interactive Response Technology (IRT) Systems including automated randomization and drug supply management, including specification design & UAT testing
- Manage study closeouts and drug reconciliation at study end
- Ensure all clinical supply related documents are filed in the eTMF
- Develop and manage clinical supply budget for assigned studies
- Oversee Clinical Supply Chain timelines to ensure on-time completion of deliverables

**Qualifications**:

- Requires a BS degree with 3+ years’ experience in a Clinical Supply Chain role in a Biotechnology or Pharmaceutical environment
- Experience managing contract packaging and labeling organizations
- Experience with developing risk-based supply strategy for an early to late-stage clinical development programs
- Thorough understanding of regulatory requirements for clinical supply distribution in US, APAC, and EU including testing and labeling requirements
- Thorough understanding of cGMP, GCP, GDP and national/international transportation requirements for pharmaceutical materials
- Global distribution experience including working with QP, IRT and regional depots.
- Excellent project management and communication skills
- Must thrive in a fast-paced innovative environment while remaining flexible, proactive, resourceful, and efficient
- Strong commitment to compliance and ethical standards
- Proficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.)
- This position does not require travel

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