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About the Role
The Senior Manager of Clinical Supply Chain will be responsible for managing multiple investigational drug supplies for world-wide oncology trials. They will oversee all aspects of clinical supply management including packaging, labeling, distribution, monitoring inventory, and vendor oversight. They will have an excellent understanding of the clinical supply packaging and labeling processes and be able to independently manage supply needs and distribution.
Responsibilities
- Develop strategic clinical supply packaging and labeling designs to fulfill clinical study dosing requirements, patient compliance, and effective study execution by sites.
- Collaborate with Pharmaceutical Development/CMC, Clinical Operations, Manufacturing, Regulatory Affairs, vendors, and others, as required, to finalize and implement designs.
- Assess labeling, packaging and distribution needs on a study-by-study basis and identify appropriate vendors to conduct this work.
- Establish agreements with these vendors.
- Manage direct outsourcing of labeling, packaging, storage, and distribution of Syndax-manufactured drug supply and co-administered and/or comparator supplies, as required, to global sites.
- Monitor inventory levels at depots and advise clinical sites on inventory levels for non-IVR/IWR supported studies through the life of a trial.
- Take preventive actions to avoid potential supply issues.
- Collaborate with external vendors to develop and approve specifications and user acceptance testing of IVR/IWR systems, where these are utilized for supply management.
- Review and request modifications when study plans change or supply algorithms to required modifications.
- Manage day-to-day orders of resupplies to sites and ISTs for studies not supported with an IVR/IWR system.
- Provide timely technical review of vendor-generated documentation and collaborate with Quality to complete final review/approvals, as required.
- Manage vendors and their respective contracts, invoice review, and budget planning.
- Establish practices and SOPs as needed, to support industry best practices.
- Collaborate with Quality to establish and regularly review Quality Agreements with vendors and partners providing packaging, labeling and/or distribution services.
- Collaborate with CMC, Quality, Regulatory and Clinical Operations, and others, as needed to ensure joint success.
- Manage end-to-end supply chain activities including accountability and reconciliation for global trials for both IRT and non-IRT trials.
- Prevent and resolve operational issues such as deviations, corrective and preventative actions, production delays, etc.
Requirements
- BS, MS or PharmD degree, and at least 6-8 years of clinical supply chain experience within pharma/biotech.
- Thorough understanding of GXPs governing the manufacture of pharmaceutical drug products and conduct of routine clinical trials distribution.
- Extensive experience in clinical supply management including logistics (labeling, packaging, distribution, expiries), inventory tracking, and managing IRT systems.
- Must be knowledgeable in US, EU, and ROW clinical supply labeling requirements and the QP review/release/certification process for European clinical supplies.
- Experience with both ambient and cold chain products.
- Must be able to effectively manage multiple activities and problem-solve to achieve business needs.
- Strong communication skills, able to work independently and collaborate with key internal and external stakeholders.
- Excellent project management skills.
- Dynamic and energetic, hands-on approach to challenges.
- Business travel, domestic and international, to various company offices, suppliers, and partners as required.
Skills
- Clinical supply chain management
- Packaging
- Labeling
- Distribution
- Inventory monitoring
- Vendor oversight
- Project management
- Communication skills
- Problem-solving
- IRT systems management
- Ambient and cold chain product handling
Location
- New York, NY
Work Type
- Remote
- Full-time
Experience Level
- Senior
- 6-8 years
Education Level
- BS
- MS
- PharmD
Salary/Compensations
- $145,000 - $165,000
Benefits
- Equity offering
- Annual target bonuses
- Outstanding benefits program
About the Company
- Syndax Pharmaceuticals is a commercial-stage biopharmaceutical company advancing innovative cancer therapies.
- Highlights of the Company’s pipeline include a menin inhibitor for R/R acute leukemia and a monoclonal antibody that blocks the CSF-1 receptor for chronic graft-versus-host disease.
- Fueled by our commitment to reimagining cancer care, Syndax is working to unlock the full potential of its pipeline and is conducting several clinical trials across the continuum of treatment.
- For more information, please visit www.syndax.com/ or follow the Company on X and LinkedIn.
Equal Opportunity
- Syndax Pharmaceuticals is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.