About Avalyn:
Avalyn aims to transform the treatment paradigm for pulmonary fibrosis and other serious, rare respiratory diseases. The company is advancing optimized inhaled formulations of established antifibrotic medicines designed to deliver drug directly to the lungs, enhance local efficacy, and reduce systemic side effects. Avalyn’s AP01 program is an optimized inhaled formulation of pirfenidone currently being evaluated in MIST, a global Phase 2b clinical trial in patients with progressive pulmonary fibrosis (PPF). AP01 has demonstrated encouraging safety and clinical activity across Phase 1b and an ongoing, multi-year open-label extension trial, with long-term data supporting the potential to preserve lung function while improving tolerability relative to historical oral pirfenidone. Avalyn’s AP02 program is an optimized inhaled formulation of nintedanib currently being evaluated in AURA, a global Phase 2 clinical trial in patients with idiopathic pulmonary fibrosis (IPF). Avalyn is also advancing AP03, an inhaled fixed-dose combination of pirfenidone and nintedanib, designed to deliver multiple antifibrotic mechanisms through a single lung-targeted platform. By leveraging its proprietary drug-device approach and deep expertise in rare respiratory disease development, Avalyn aims to establish a new standard of care in pulmonary fibrosis through inhaled, lung-targeted therapies. For more information, please visit avalynpharma.com and follow the company on LinkedIn.
Position Overview:
Avalyn is seeking an experienced Senior Director, Head of Supply Chain to build and lead the company’s supply chain function as its clinical programs advance through later-stage development. Reporting to the SVP, Product Development, this leader will have end-to-end responsibility for clinical supply chain strategy and execution across Avalyn’s portfolio, with a focus on ensuring uninterrupted supply for complex global Phase 2 and Phase 3 clinical studies.
This role is designed for a leader who can take direct ownership of current global clinical supply execution while building the supply chain organization, processes, systems, and partner network needed to support Avalyn’s continued growth. This is a hands-on, execution-oriented leadership position for someone who can move seamlessly between strategic planning and operational execution. The successful candidate will integrate clinical demand with CMC and manufacturing plans, manage multiple concurrent global programs, and build scalable supply chain capabilities to support late-stage development and future commercialization.
This is an opportunity for the candidate to shape Avalyn’s supply chain function during its pivotal growth stage, with broad visibility across the organization and direct impact on global clinical execution.
Key Responsibilities:
Clinical Supply Strategy & Execution
- Lead end-to-end clinical supply chain strategy, planning, and execution across Avalyn’s development portfolio, with emphasis on complex global Phase 2 and Phase 3 programs.
- Develop integrated supply plans that connect clinical demand, manufacturing schedules, drug product, device, components, packaging, labeling, release, distribution, and site resupply needs.
- Partner closely with CMC, Clinical Operations, Quality, Regulatory Affairs, Program Management, and external partners to anticipate supply risks and align execution plans with program priorities.
- Oversee demand forecasting, supply planning, inventory management, expiry monitoring, packaging and labeling, depot strategy, distribution, returns, reconciliation, and destruction activities.
- Lead supply chain input and partner cross-functionally on IRT/RTSM design and supply configuration to support efficient inventory management and site resupply.
- Develop scenario plans and mitigation strategies for manufacturing delays, enrollment changes, supply constraints, country activation shifts, or other operational disruptions.
External Partner Management, Organizational Leadership & Readiness
- Lead and oversee relationships with external packaging, labeling, logistics, depot, distribution, clinical supply, CDMO, and manufacturing partners, ensuring clear expectations, timely escalation, and performance oversight.
- Build scalable supply chain processes, systems, tools, governance, metrics, and reporting appropriate for Avalyn’s stage of development.
- Provide senior leadership with clear, decision-ready visibility into supply status, risks, tradeoffs, mitigation options, budget implications, and required decisions.
- Support late-stage development and clinical-to-commercial supply readiness, including registration/validation batches, PPQ readiness, launch planning, and transition from clinical to commercial supply.
- Help define the future Supply Chain organization, including capabilities, systems, vendors, and resources needed to support Avalyn’s next stage of development.
Qualifications:
- A minimum of a Bachelor’s degree in Supply Chain, Operations, Engineering, Life Sciences, Business, or a related discipline required; An advanced degree (i.e. MS, PharmD, PhD or equivalent) is preferred.
- 12+ years of progressive supply chain experience in the pharmaceutical or biotechnology industry, with significant responsibility for clinical supply.
- Direct Phase 2 and Phase 3 clinical supply experience required, including responsibility for complex, concurrent global clinical trials or programs.
- Strong experience in demand forecasting, supply planning, inventory management, packaging and labeling, global distribution, depot strategy, and IRT/RTSM-supported supply planning.
- Demonstrated experience integrating clinical demand with manufacturing, CMC, Quality, Regulatory, and program-level supply plans.
- Significant experience managing outsourced clinical supply partners, including packaging, labeling, logistics, depots, distribution vendors, CDMOs, and manufacturing organizations.
- Experience with drug-device combination products, inhaled therapies, complex delivery systems, or products involving multiple interdependent components strongly preferred.
- Experience supporting late-stage clinical development and clinical-to-commercial supply readiness, including registration/validation batches, PPQ readiness, launch planning, and transition from clinical to commercial supply, strongly preferred.
- Working knowledge of applicable GxP requirements and global regulatory expectations related to clinical supply.
- Demonstrated ability to operate effectively in a hands-on, execution-focused environment while balancing day-to-day problem solving with strategic supply planning.
- Strong leadership competencies, including accountability, prioritization, vendor governance, risk management, financial discipline, and clear communication of supply status and risks to senior leadership.
