Clinical Supply Chain Manager

2 weeks ago

Watertown, Massachusetts, United States Syndax Pharmaceuticals Full time

Company Overview:

Syndax Pharmaceuticals is dedicated to creating a future where individuals battling cancer can enjoy extended and improved lives. As a clinical-stage biopharmaceutical organization, we are focused on developing a groundbreaking pipeline of cancer treatments.

Position Summary:

The Clinical Supply Chain Manager will play a pivotal role in overseeing the management of investigational drug supplies for various global oncology trials. This position entails comprehensive oversight of clinical supply management, including packaging, labeling, distribution, inventory monitoring, and vendor management.

Key Responsibilities:

  • Design and implement clinical supply packaging and labeling to meet dosing requirements and ensure patient compliance for various programs.
  • Collaborate with cross-functional teams including CMC, Clinical Operations, Quality Assurance, Medical Affairs, and Regulatory Affairs to finalize and execute supply designs.
  • Evaluate labeling, packaging, and distribution requirements on a per-study basis and identify suitable vendors for these services.
  • Oversee the outsourcing of labeling, packaging, storage, and distribution of both Syndax-manufactured and co-administered drug supplies to global sites.
  • Translate clinical protocols into accurate supply forecasts to determine necessary drug supply quantities and production schedules.
  • Monitor inventory levels at depots and provide guidance to clinical sites regarding inventory status throughout the trial lifecycle.
  • Work with external vendors to establish specifications and conduct user acceptance testing for supply management systems.
  • Manage daily resupply orders for studies not utilizing an IRT system.
  • Conduct timely technical reviews of vendor documentation and collaborate with Quality for final approvals.
  • Develop and maintain standard operating procedures (SOPs) to support industry best practices.
  • Partner with Quality to establish and routinely review Quality Agreements with vendors providing packaging, labeling, and distribution services.
  • Collaborate with various departments to ensure collective success in supply chain activities.
  • Handle end-to-end supply chain operations, ensuring accountability and reconciliation for global trials.
  • Proactively address and resolve operational challenges such as deviations and production delays.

Qualifications:

The ideal candidate will possess a BS, MS, or PharmD degree along with 5-7 years of experience in clinical supply chain management within the pharmaceutical or biotechnology sectors. APICS certification or relevant coursework is preferred.

Candidates should have a comprehensive understanding of regulatory guidelines governing pharmaceutical manufacturing and clinical trial distribution, along with extensive experience in logistics, inventory tracking, and IRT systems management.

Knowledge of clinical supply labeling requirements across various regions, as well as experience with both ambient and cold chain products, is essential. Strong communication skills, the ability to manage multiple projects effectively, and excellent problem-solving capabilities are crucial for success in this role.

Travel Requirements:

This position may require business travel to various locations as necessary.

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