Avalyn is seeking a Director, Supply Chain, to join our team. We are focused on enhancing the lives of patients with rare respiratory diseases through the development of innovative inhaled therapies. The Company’s lead asset is Phase 2b/3-ready for the treatment of pulmonary fibrosis.

The Director, Supply Chain will focus on ensuring continuous supply for Avalyn’s clinical trial materials. This position will report to SVP, Product Development and will work with Clinical, Quality and Project Management, as well as with Contract Manufacturing Organizations (CMOs) to accomplish project objectives and timeline, and to ensure product integrity and regulatory compliance are met. This position will develop strategies for labeling, packaging, and distribution of study drug and devices, manage and maintain clinical supplies. 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. The Director will participate as an active member of the team to plan and manage the clinical supply tasks required for phase 1 – 4 studies.

Responsibilities:

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

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

· Create and manage CTM forecasts for all Avalyn Pharma clinical programs.

· 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.

· Manage global clinical supply logistics and distribution activities.

· Develop forecast for clinical packaging, labeling, and distribution activities.

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

· Participate in the development and implementation of IRT for each study.

· 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.

The ideal candidate for this role will have:

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

· 10+ years of pharmaceutical industry experience within clinical supply chain management (respiratory product development experience 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 clinical trial is desirable

· Demonstrated experience with managing supplies for multiple, parallel clinical trials

· Experience in CMO management, including labeling, packaging, and distribution in North America and rest of world

· Strong understanding of Clinical Protocols and Study Designs, and hands on experience in implementation of IRT systems

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

· Understands the need for growth and is receptive to constructive feedback.

Other Requirements:

· 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.

*People located in San Diego, CA will be given preference *Pay rate will be based on qualifications and education

This is a remote position.