[Hiring] Senior Manager, Clinical Supply Chain @Syndax Pharmaceuticals

Role Description

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.

• 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.

Qualifications

• BS, MS or PharmD degree, and at least 6-8 years of clinical supply chain experience within pharma/biotech.
• APICS certification or coursework is desired.
• 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.
• 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.
• 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.

Requirements

• Must be able to effectively manage multiple activities and problem-solve to achieve business needs.
• Business travel, domestic and international, to various company offices, suppliers, and partners as required.

Benefits

• Total compensation and rewards package that is among the most competitive in the industry.
• Base pay determined within a range based on several factors including market data, experience, qualifications, demonstrated skills, relevant education or training, travel requirements and internal equity.
• Overall package includes an equity offering, annual target bonuses, and an outstanding benefits program.
• Anticipated annualized salary range for this role is $145,000 - $165,000.