Backed by Norwest.
About the role
The Associate Director, Nonclinical Development will serve as a key scientific contributor within the Translational Sciences organization, supporting the advancement of Avalyn's pipeline through pre-clinical and clinical development stages. This individual will contribute to integrated development strategies that leverage pharmacology, translational science, biomarkers, and nonclinical evidence packages to inform candidate progression, dose selection, regulatory submissions, and clinical development plans.
What they're looking for
- Ph.D. (or equivalent degree) in Pharmacology, Physiology, Pulmonary Biology, Biochemistry, or a closely related field is required
- A minimum of 7-10 plus years of relevant industry experience in translational sciences, nonclinical pharmacology, or related functions within biopharmaceutical drug development is required
- Demonstrated experience with inhaled drug delivery and/or respiratory pharmacology is highly preferred
- Deep knowledge of pulmonary fibrosis biology and relevant in vitro , ex vivo , and in vivo disease models is required, familiarity with complex signaling pathways is a plus
- Familiarity with biomarker strategy, including identification, qualification, and application in early-phase clinical trials
- Exceptional scientific writing skills with demonstrated experience serving as a primary author for regulatory submissions, development plans, study reports, investigator brochures, briefing books, and manuscripts
More about this role
Avalyn aims to transform the treatment paradigm for pulmonary fibrosis and other serious, rare respiratory diseases. The company is advancing optimized inhaled formulations of established antifibrotic medicines designed to deliver drug directly to the lungs, enhance local efficacy, and reduce systemic side effects. Avalyn’s AP01 program is an optimized inhaled formulation of pirfenidone currently being evaluated in MIST, a global Phase 2b clinical trial in patients with progressive pulmonary fibrosis (PPF). AP01 has demonstrated encouraging safety and clinical activity across Phase 1b and an ongoing, multi-year open-label extension trial, with long-term data supporting the potential to preserve lung function while improving tolerability relative to historical oral pirfenidone. Avalyn’s AP02 program is an optimized inhaled formulation of nintedanib currently being evaluated in AURA, a global Phase 2 clinical trial in patients with idiopathic pulmonary fibrosis (IPF). Avalyn is also advancing AP03, an inhaled fixed-dose combination of pirfenidone and nintedanib, designed to deliver multiple antifibrotic mechanisms through a single lung-targeted platform. By leveraging its...
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