Associate Director, Clinical Supply Chain

Role Summary

As Associate Director of Clinical Supply Chain, you will ensure investigational medicinal products (IMP) and other clinical supplies are planned, labeled, packaged, and delivered on time, in compliance with regulatory requirements, and aligned with study needs. This is a hybrid role with remote work and based at the company's headquarters in Watertown, MA.

Responsibilities

• Manage clinical supply planning and forecasting for Disc's small molecule program.
• Serve as member of the clinical study team and/or clinical drug supply team.
• Review clinical study protocols to develop packaging/labeling designs, label pack timelines and distribution strategies.
• Ensure supply demand is clearly communicated to the technical operations/QA team so manufacturing and release activities align with the organization timelines.
• Collaborate closely with labeling and packaging CDMO's to ensure operation dates align with clinical timelines.
• Responsible for developing and maintaining strong relationships with external vendor(s)/partner(s) who provide resources and services that are critical to the success of Disc objectives and deliverables.
• Coordinate QP release for global studies.
• Review pharmacy manuals and clinical site SOPs.
• Budgeting, forecasting, and strategic planning activities for clinical trials.
• Drive the sourcing of the clinical supply service provider as needed.
• Coordinate the origination, translations, proofing and approval of clinical study labels.
• Participate in the configuration and UAT testing of the IRT, if applicable.
• Primary contact and project manager for the labeling and packaging services provider associated with the clinical study.
• Coordinate drug supply delivery timelines with Supply Chains operations planning, CMC and the label/pack service providers.
• Monitor global clinical supply inventory at the depot and clinical site levels.
• Maintain close communications with all internal groups to ensure the adequate supply of clinical supplies throughout the duration of a clinical trial.
• Meet with Clinical Operations as needed to update study assumptions (i.e., enrollment rates) and to update supply plans.
• Collaborate closely with Reg-CMC and Quality Assurance.
• Serve as author and reviewer for IND and IMPD submissions, as applicable.
• Provides visibility to potential risks in planned capacity and makes recommendations with strategic direction.
• Assist with creation or review of SOPs as needed.

Qualifications

• Bachelor's degree in a related field (e.g., Supply Chain Management, Life Sciences, Pharmacy, or Business)
• 10+ years of experience specifically in clinical supply
• Experience working with clinical packaging, labeling, and distribution service providers
• Proficiency in developing supply forecasting and inventory management excel tools
• Strong understanding of clinical trial operations, regulatory requirements, and GMP/GCP/GDP guidelines
• Experience with IRT systems for clinical supply management