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Clinical Supply Chain Manager
2 months ago
Company Overview:
Syndax Pharmaceuticals is committed to advancing the future of cancer treatment, ensuring that individuals diagnosed with cancer can lead longer and improved lives.
Position Summary:
The Clinical Supply Chain Manager will oversee the management of investigational drug supplies for various global oncology trials. This role encompasses all facets of clinical supply management, including packaging, labeling, distribution, inventory monitoring, and vendor management.
Key Responsibilities:
1. Develop clinical supply packaging and labeling to meet dosing requirements and enhance patient compliance for Syndax's Early Access Program, Compassionate Use, IST, and Collaborative studies.
2. Collaborate with CMC, Clinical Operations, Quality Assurance, Medical Affairs, Regulatory Affairs, and vendors to finalize and implement supply designs.
3. Assess the packaging, labeling, and distribution needs for each study and identify suitable vendors for these tasks, establishing agreements as necessary.
4. Manage the outsourcing of labeling, packaging, storage, and distribution of both Syndax-manufactured and co-administered drug supplies to global sites.
5. Translate clinical protocols into supply forecasts to determine required drug supply quantities and schedule production accordingly.
6. Monitor inventory levels at depots and advise clinical sites on inventory for non-IRT supported studies throughout the trial duration, taking preventive measures to mitigate potential supply issues.
7. Collaborate with external vendors to develop and approve specifications and conduct user acceptance testing of IRT systems utilized for supply management.
8. Review and request modifications in response to changes in study plans.
9. Manage daily resupply orders for studies not supported by an IRT system.
10. Provide timely technical reviews of vendor-generated documentation and work with Quality to finalize approvals as required.
11. Establish practices and SOPs to support industry best practices.
12. Collaborate with Quality to establish and regularly review Quality Agreements with vendors and partners involved in packaging, labeling, and distribution services.
13. Work closely with CMC, Quality, Regulatory, and Clinical Operations to ensure collective success.
14. Oversee end-to-end supply chain activities, ensuring accountability and reconciliation for global trials, both IRT and non-IRT.
15. Proactively prevent and resolve operational issues such as deviations, corrective actions, production delays, etc.
Qualifications:
1. BS, MS, or PharmD degree with a minimum of 5-7 years of experience in clinical supply chain management within the pharmaceutical or biotechnology sectors.
2. APICS certification or relevant coursework is preferred.
3. In-depth knowledge of GXPs governing pharmaceutical drug product manufacturing and routine clinical trial distribution.
4. Extensive experience in clinical supply management, including logistics (labeling, packaging, distribution, expiries), inventory tracking, and IRT systems management.
5. Familiarity with US, EU, and ROW clinical supply labeling requirements and the QP review/release/certification process for European clinical supplies.
6. Experience with both ambient and cold chain products.
7. Ability to effectively manage multiple tasks and problem-solve to meet business objectives.
8. Strong communication skills, capable of working independently and collaborating with key internal and external stakeholders.
9. Excellent project management capabilities.
10. A dynamic and energetic approach to challenges.
Travel Requirements:
Business travel may be necessary to various company offices, suppliers, and partners as required.
