Associate Director / Sr. Manager, Clinical Supplies

W2 contract role based in Redwood City, CA – hybrid schedule.

About the role

The Clinical Supply Manager is responsible for the supply strategy and management of clinical trial supplies for the company. This position reports to Clinical Operations and partners with Clinical Supply Chain to ensure adequate clinical supplies from study initiation through completion. Clinical trial supplies include investigational medicinal products and non-investigational medicinal products as per the study protocol.

Responsibilities

• Ensure adequate clinical trial supplies are available for each study.
• Act as the clinical supply lead for each Study Management Team (SMT).
• Manage, forecast, order, and track supplies.
• Identify and communicate potential risks, define, and execute risk mitigation plans.
• Oversee daily CMO activities from drug product release to study close-out.
• Attend SMT meetings and external vendor teleconferences.
• Communicate supply plans effectively.
• Communicate levels of clinical trial material and impact on clinical supply.
• Participate in the management of IRT systems.
• Report to management.
• Plan sufficient inventory supply and manage adequate levels.
• Understand GMP manufacturing and IP release processes.
• Manage a CMO (labeling/distribution) vendor.
• Identify and communicate constraints effectively.
• Track various supply chain activities.
• Problem-solve supply chain constraints.
• Provide input into user requirement specifications of Interactive Response Technology (IRT) medication management module(s) as needed.
• Review the IRT dispensation strategy to ensure it supports supply plans.
• Ensure that IRT settings are optimized based on projections.
• Execute IRT User Acceptance Testing.
• Leverage the inventory management capabilities of the IRT and other data sources for reporting.
• Devise and implement inventory management plans.
• Create, review, implement, and maintain IP forecasts.
• Collaborate with the Clinical Operations Team on annual and periodic projections/reviews.
• Manage IP distribution in partnership with Clinical Operations team members and the vendor.
• Proactively identify potential supply chain issues to recommend solutions.
• Create and maintain inventory and demand trackers utilizing IRT and other data sources.
• Monitor consumption and schedule shipments to resupply regional depots.
• Update inventory and demand slides for individual SMT meetings.
• Develop and maintain metrics for management to review.
• Co-lead planning, labeling, and distribution meetings.
• Schedule ad-hoc shipments for non-IRT-managed studies.
• Perform other duties based on current needs.

Requirements

• Bachelor’s degree or higher in operations management or a science-related field (equivalent work experience may be considered).
• Minimum of 4-5 years of clinical supply chain management experience; global experience is preferred.
• Strong project management skills with 2-3 years of experience.
• Experience with IRT/IXRS/IWRS required.
• Experience in building and managing forecasts for clinical supply chains.
• Knowledge of relevant GMPs, GCPs, GDPs, and other regulations.
• Excellent computer skills, including Microsoft Suite; advanced Excel skills are a plus.

Pay

$65 - $75 per hour.