Supply Chain Lead

Avalo Therapeutics•Chesterbrook, PA

1d•Hybrid

About The Position

Avalo Therapeutics is seeking a strategic and hands-on Supply Chain Lead to lead global clinical supply operations across programs ranging from early development through late-stage clinical studies. This is a highly visible opportunity to help build and scale clinical supply capabilities as Avalo and its pipeline continue to grow. As a key member of the CMC Biologics team, you will oversee the end-to-end clinical supply lifecycle, including demand forecasting, IRT, packaging and labeling, inventory management, global distribution and logistics, and external vendor oversight. You will partner cross-functionally to anticipate supply needs, manage risk, and ensure reliable drug supply to support our global clinical programs and the patients they serve.

Requirements

Bachelor’s degree in Business Administration, Pharmacy, Biology or related science with minimum 5 years of experience in the pharmaceutical industry with a focus in clinical supplies and global supply chain management.
Experience in SD&OP activities supporting clinical trial supply.
Exceptional project management, analytical, and problem-solving skills with a demonstrated ability to manage multiple priorities.
Strong understanding of the drug supply, distribution and packaging process.
Demonstrated experience in strategic supply chain and supplier relationship management.
Knowledge of the global clinical supply and clinical study processes, of cGMP and GCP regulations, ICH Guidelines as it relates to Good Distribution Practices (GDPs) and local country drug shipment regulations.
Advanced knowledge of fundamental concepts of materials requirements, planning, and procurement including: inventory management, Supply Demand and Operations Planning, expediting, third party supplier work order reviews, contract updates, and order placement
Advanced knowledge of the full range of concepts, practices in the materials planning field, including reorder point planning, contract communication/execution
Capability to work in a changing environment and beyond pre-defined processes.
Demonstrated success working effectively with cross-functional teams to get results through effective skills in negotiation, priority management communication (works in transparency), problem solving and decision-making.
Knowledge of supply chain concepts and practices in Biopharmaceutical industry
Knowledge of international customs & trade, taxation, transfer pricing and cGMP regulatory requirements

Nice To Haves

APICS certification (CSCP/CPIM) desirable

Responsibilities

Lead end-to-end global clinical supply operations across early- through late-phase clinical studies, ensuring reliable supply throughout the study lifecycle.
Own clinical supply forecasting and demand planning, translating enrollment, dosing, treatment duration, study timelines, and protocol changes into manufacturing, packaging, labeling, and distribution requirements.
Develop and execute integrated clinical supply plans and manufacturing schedules, ensuring drug product, materials, and resources are available to meet program and study milestones.
Lead packaging, labeling, IRT, SKU planning and release, inventory management, global distribution, returns, reconciliation, and destruction activities through third-party providers.
Drive S&OP/SD&OP activities for clinical programs, balancing demand, manufacturing capacity, inventory, study assumptions, and program timelines.
Establish strategic direction for clinical supply outsourcing and lead external vendor relationships, including packaging and labeling providers, logistics partners, depots, and other third-party supply organizations.
Monitor inventory, manufacturing and supply metrics, release timelines, and key milestones; proactively identify supply risks, shortages, or delays and implement mitigation and contingency plans.
Serve as the clinical supply subject matter expert and primary point of contact for supply planning, operational issues, and ad hoc supply chain analyses.
Partner closely with Clinical Operations, CMC, Quality, Regulatory, and other cross-functional stakeholders to align clinical supply strategy with study execution and broader development plans.
Ensure clinical supply operations comply with applicable cGMP, GCP, GDP, international shipping, customs, and country-specific regulatory requirements.
Build and scale clinical supply capabilities, processes, systems, vendor strategies, and operating practices as Avalo advances into larger, global, and increasingly complex late-stage clinical studies.