Senior Manager, Clinical Supply Chain

Syndax Pharmaceuticals•New York, NY

2h•$145,000 - $165,000•Remote

About The Position

The Senior Manager of Clinical Supply Chain manages multiple investigational drug supplies for worldwide oncology trials and oversees clinical supply management, including packaging, labeling, distribution, inventory monitoring, and vendor oversight. The role requires a thorough understanding of clinical supply packaging and labeling processes and the ability to independently manage supply needs and distribution. The position manages end-to-end supply chain activities for global trials, including accountability and reconciliation for IRT and non-IRT trials. It works closely with internal functions and external vendors to support study execution and resolve operational issues.

Requirements

BS, MS, or PharmD degree.
At least 6–8 years of clinical supply chain experience within pharma or biotech.
Thorough understanding of GXPs governing pharmaceutical drug product manufacture and routine clinical trial distribution.
Extensive clinical supply management experience, including logistics such as labeling, packaging, distribution, and expiries; inventory tracking; and IRT systems.
Knowledge of US, EU, and ROW clinical supply labeling requirements and the QP review, release, and certification process for European clinical supplies.
Experience with both ambient and cold-chain products.
Ability to manage multiple activities effectively and problem-solve to achieve business needs.
Strong communication skills and ability to work independently and collaborate with internal and external stakeholders.
Excellent project management skills.
Dynamic, energetic, hands-on approach to challenges.
Ability to travel domestically and internationally to company offices, suppliers, and partners as required.

Nice To Haves

APICS certification or coursework.

Responsibilities

Develop strategic clinical supply packaging and labeling designs to meet study dosing requirements, patient compliance needs, and effective site execution; collaborate with Pharmaceutical Development/CMC, Clinical Operations, Manufacturing, Regulatory Affairs, vendors, and others to finalize and implement designs.
Assess labeling, packaging, and distribution needs for each study, identify suitable vendors, and establish vendor agreements.
Manage outsourcing of labeling, packaging, storage, and distribution of Syndax-manufactured drug supply, co-administered supplies, and comparator supplies for global sites.
Monitor depot inventory and advise clinical sites on inventory levels for studies without IVR/IWR support; take preventive action to avoid supply issues.
Work with external vendors to develop and approve IVR/IWR system specifications and user acceptance testing; review and request modifications when study plans or supply algorithms change.
Manage day-to-day resupply orders to sites and ISTs for studies without IVR/IWR support.
Provide timely technical review of vendor documentation and collaborate with Quality on final reviews and approvals.
Manage vendors and their contracts, review invoices, and plan budgets.
Establish practices and SOPs as needed to support industry best practices.
Collaborate with Quality to establish and regularly review Quality Agreements with packaging, labeling, and distribution vendors and partners.
Collaborate with CMC, Quality, Regulatory, Clinical Operations, and other stakeholders to support joint success.
Manage end-to-end supply chain activities, including accountability and reconciliation, for global IRT and non-IRT trials.
Prevent and resolve operational issues, including deviations, corrective and preventive actions, and production delays.