Job Description
Company Overview:
Avalyn Pharma is developing innovative, inhaled therapies to target the lungs for treatment of rare respiratory diseases, including idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF). Avalyn completed an oversubscribed $175M Series C financing in September 2023 to advance our clinical-stage pulmonary fibrosis portfolio consisting of inhaled pirfenidone (AP01), inhaled nintedanib (AP02), and a fixed-dose combination of both (AP03). Currently, treatment for IPF and PPF includes the oral antifibrotics, pirfenidone and nintedanib. Due to side effects, 30-50% of patients cannot tolerate these medications. Avalyn has developed inhaled formulations for these FDA-approved antifibrotics. AP01 has now been studied in over 180 patients with various forms of pulmonary fibrosis, over at least 48 weeks and some out to 4 years and is phase 2b ready. PK studies show that AP01 reaches 35 times the concentration in the lung with 1/15th of the systemic concentration compared to historic oral pirfenidone. AP01 has demonstrated efficacy in the ATLAS study, with a high dose achieving near stabilization of lung function and is well tolerated with fewer systemic adverse events vs. historic oral pirfenidone. We have also completed a phase 1a study of AP02, an inhaled formulation of nintedanib, and is on pace to complete the phase 1b SAD/MAD study in 2024, with phase 2 plans being planned for late 2025. Phase 1a positive topline results were announced in March 2023, and AP02 was demonstrated to be safe and well tolerated in normal volunteers & IPF patients in that study.
Position Overview:
Avalyn is seeking a highly motivated individual at the Director/Senior Director level to join its Product Development team. This individual will play a key role in advancing Avalyn’s lead AP01 program and expanding the Avalyn product pipeline to treat rare lung diseases. This is a remote position and will be reporting to the Senior Vice President, Product Development.
Key Responsibilities:
• Together with SVP Product Development:
o provide strategic leadership, technical expertise and specialized knowledge in developing drug/device combination product
o develop and implement comprehensive plans to meet all aspects of CMC needs that include drug substance, drug product, device and analytics
o plan CMC development timeline and oversee the execution of CMC activities for the company to ensure regulatory compliance, quality and timelines are met
o plan, develop and employ project-specific CMC resource and budget plan to ensure agreed goals and spending targets are met
o lead formulation research and product development of company pipeline product opportunities
o participate in planning and execution of commercial scale up activities for the manufacture of drug, device and packaging of drug/device combination product
o manage human factor studies and design-history-file of the drug/device combination product
• Work with senior management and other project team members to select and qualify CMOs/CROs
• Communicate effectively and transparently with functional heads within pharmaceutical development and other company stakeholders (Quality, Toxicology/DMPK, Clinical/Regulatory, Operations, Project, etc.)
• Provide clinical packaging/labeling oversight
• Work with packaging/labeling CMO to maintain adequate clinical supply inventory to support ongoing clinical studies. Provide technical expertise to contribute to new project selection for the company
• Contribute significantly to lead selection/optimization, formulation development/process and clinical development of pipeline asset(s) selected for program advancement
• Provide support to CMC writing for regulatory submissions, board update, due diligence, etc. Work collaboratively and cross-functionally with other key leaders to ensure the proper execution of organizational goals
The ideal candidate for this role will have:
• A PhD or advanced degree in Pharmaceutics, Chemical Engineering or equivalent with 15+ years of industrial experience
• Demonstrated breadth and depth in developing drug-device combination product from early to late stage
• Direct experience in process development and manufacturing of sterile solution-based drug products
• Hands-on experience in leading human factor studies and compiling design history file (DHF) for drug device combination product
• Direct experience in managing clinical labeling and packaging of clinical supplies with CMOs
• Experience in managing CMC/analytical activities at different stages of drug development programs
• Have authored relevant pre-IND, IND and NDA CMC/analytical sections
• Preference will be given to candidates with direct CMC/analytical experience in approved inhalation drug products
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