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DirectorSr Director Clinical Development
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- 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).
- 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.
- Cross collaborates with Sr. VP Clinical Development, VP Clinical Operations, VP Medical Affairs, and Sr. VP, Program Management to co-create the clinical development plan to ensure that market needs are met, including clinical trial design, clinical indication, choice of potential comparator, implementation of imaging and biomarker plan.
- Responsible for providing clinical development insights into the Target Product Profiles, Clinical Development Plans, Pediatric Investigational Plan, core Clinical Trial Protocols, Project Analysis and Data Management Plan, Investigator Brochure, Annual Safety Report / IND Safety Reports, preparation for the Milestones Start of Development, Proof of Clinical Principle, Release of Full Development, and input into regulatory strategies and labeling discussions.
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