Backed by Norwest.
About the role
The Director, Clinical Development will report to the Senior Vice President, Clinical Development, providing IPF/ILD medical oversight, scientific leadership, and clinical expertise throughout the lifecycle of clinical trials, from protocol strategy and design through execution, data interpretation, clinical study reporting, and regulatory interactions.
What they're looking for
- Advanced clinical or scientific degree (e.g., APRN, RRT, PhD, PharmD) with 5–7+ years of experience in IPF/ILD clinical care, research, or drug development
- A minimum of 3–5+ years of clinical development experience, with demonstrated involvement in the design and execution of Phase 2–3 clinical trials, preferably global studies
- Therapeutic expertise in IPF, ILD, or a closely related respiratory disease area is required
- Demonstrated expertise in clinical trial protocol development, including endpoints, eligibility criteria, safety monitoring, and risk mitigation strategies
- Strong clinical judgment and commitment to patient safety, with experience evaluating safety signals, protocol deviations, and benefit-risk considerations
- Experience reviewing and interpreting clinical safety and efficacy data and translating findings into meaningful clinical and development decisions
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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