Company Overview:

Avalyn is reimagining the future of pulmonary fibrosis treatment with a pipeline of new inhaled formulations of approved medicines designed to reduce systemic exposure and deliver medication directly to the site of disease. Pulmonary fibrosis is characterized by scarring of lung tissue, decline in lung function, and reduced exercise capacity and quality of life, and is associated with increased mortality. Currently approved therapeutic options slow pulmonary fibrosis progression but are associated with significant toxicities that restrict their use and dosing. Avalyn’s inhaled approach tackles the underlying pathophysiology of pulmonary fibrosis at its source and is designed to reduce systemic exposure and deliver medication directly to the site of disease. Avalyn’s AP01 is an optimized inhaled formulation of pirfenidone, currently being studied in the ongoing MIST Phase 2b study in progressive pulmonary fibrosis (PPF). AP01 has been assessed in over 150 individuals with different forms of pulmonary fibrosis and demonstrated clinical proof-of-concept with improved efficacy and safety compared to historical data with existing therapies. The company completed two Phase 1 studies for AP02, inhaled nintedanib, for the treatment of idiopathic pulmonary fibrosis (IPF) and is planning a Phase 2 clinical trial. For more information, please visit avalynpharma.com and follow us on LinkedIn.

Position Overview:

The Director, Supply Chain will focus on ensuring continuous supply for Avalyn’s clinical trial materials, including drug–device combination products used across Avalyn’s inhaled therapy portfolio. This leader will collaborate cross-functionally with Clinical, Quality, Regulatory, and Project Management, as well as Contract Manufacturing Organizations (CMOs) and device manufacturers globally to accomplish project objectives and timelines. The role includes developing strategies for labeling, packaging, and distribution of study drug and associated devices, overseeing global inventory, and ensuring regulatory compliance across multiple regions. The Director will play a key role in planning and managing clinical supply activities required for Phase 1–4 studies worldwide. This position will also be responsible for hands-on monitoring and tracking inventory levels, identifying potential supply chain issues and providing feedback and recommendations to the appropriate resources regarding demand, expiry and resupply of products. This position will report to SVP, Product Development.

Key Responsibilities:

· Develop and implement strategies for manufacturing, labeling, packaging, device handling, distribution, and return of clinical trial materials (CTMs), including drug–device combination products, to support early- to late-stage clinical trials.

· Manage end-to-end global supply logistics, including international shipment planning, temperature-controlled distribution, and regional customs/export requirements.

· Develop forecasts for clinical packaging, labeling, and distribution activities. Create and maintain global CTM inventory at multiple depots to ensure uninterrupted supply across US, EU, and rest-of-world clinical sites. Develop RFPs and manage clinical supply packaging/labeling contract with vendors

· Partner with Clinical Operations, Quality, Regulatory and Project Management to ensure timely delivery of CTM to clinical sites in compliance with global regulatory requirements.

· Select CTM labeling and packaging vendors and participate in vendor audits, as applicable.

· Maintain CTM inventory at multiple study depots to ensure sufficient inventory at clinical sites.

· Work closely with the Finance Department to ensure the cost and movement of CTMs are accurately reported, providing finance with reports of monthly activity and ending balances.

· Procure comparator or commercial products as needed to support clinical trials.

· Direct and provide oversight to CTM packaging and labeling activities at vendors and distribution of clinical supplies to depots and clinical sites.

· Provide operational and financial planning and maintenance of clinical supplies.

· Serve as the primary point of contact for all CTM supply chain activities, internally and externally to clinical supply chain vendors and contractors.

· Review clinical trial documents, such as investigator brochures and clinical study protocols to understand impact on supply and to strategically design supply plans to ensure continuous support for clinical trials.

· Coordinate review of packaging/labeling batch records and other quality-related documentations for release of study drug and devices.

· Manage package and label development/approval process and distribution timelines.

· Act as the unblinded contact for Avalyn Pharma on all blinded studies.

· Oversee the return of malfunctioned devices and defective products to manufacturer for analysis and replacement.

· Participate in the development and implementation of IRT systems to support global trials and ensure accurate tracking of drug-device supplies.

· Promotes a feedback culture and constantly improving their own and their teams' skills through lessons-learned reviews at project completion.

· May manage, coach, and mentor direct reports.

Key requirements for this role are:

· Bachelor’s degree in life sciences, supply chain management, engineering, or business major

· 10+ years of pharmaceutical industry experience in clinical supply chain management, including direct experience supporting combination drug–device products or inhaled delivery systems (respiratory product development strongly preferred).

· Certification in Supply Chain Management (APICS CIPM/CSCP) preferred

· Proven past experiences in supply chain leadership role with a strong track record of achievement through pivotal trials

· Direct experience in launching CTMs for a large global clinical study is desirable

· Demonstrated experience managing global clinical supply chains, including labeling, packaging, distribution, and CMO/third-party vendor oversight across North America, EU, and other international regions.

· Hands-on experience managing clinical supplies for multiple, parallel trials and navigating global regulatory requirements (e.g., EU Annex 13, FDA, MHRA).

· Strong understanding of clinical protocols and study designs, and hands-on experience implementing IRT systems for global trials.

· Thorough understanding of global regulatory requirements related to labeling, packaging, and distribution of drug-device CTMs

· Self-motivated, independent, and able to work effectively in a small team and fast-paced environment who understands the need for growth and is receptive to constructive feedback

· Domestic and international travel is required to visit and audit vendors, attend training, and conferences (up to 10%)

· To ensure that the highest level of services is provided, additional duties may be assigned, and evening, weekend and holiday work may be required