Avalyn Pharma

Supply Chain

• 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.

Director, Supply Chain

Clinical Operations

• Develop and execute a comprehensive strategic vision for the clinical operations department, ensuring alignment with Avalyn’s broader organizational objectives.
• Lead the planning, initiation, execution, and closure of all clinical trials globally, including complex, early-phase, and late-phase studies.
• Oversee departmental resource planning, including budget allocation, staffing, and infrastructure.
• Ensure all clinical operations adhere to relevant regulations (FDA, EMA, ICH-GCP) and internal quality standards.
• Establish and maintain strategic relationships with external vendors, CROs, laboratories, and other service providers.
• Identify potential risks in clinical trial execution, including data integrity, patient safety, and protocol adherence.
• Build and lead a robust, motivated clinical operations team.
• Collaborate closely with internal stakeholders (Senior Leadership, Clinical Development, Medical Affairs, Regulatory) and external partners to align clinical operations with organizational strategy.
• Oversee the use of data, KPIs, and metrics to monitor trial progress, quality, and operational performance.

Director, Supply Chain

Vice President, Clinical Operations