About Avalyn
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 proprietary drug-device approach and deep expertise in rare respiratory disease development, Avalyn aims to establish a new standard of care in pulmonary fibrosis through inhaled, lung-targeted therapies. For more information, please visit avalynpharma.com and follow the company on LinkedIn.
Position Overview:
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.
Reporting to the VP, Translational Sciences, the role requires strong pharmacology expertise, excellent scientific judgment, and exceptional technical writing skills to effectively synthesize and communicate complex data to cross-functional teams, regulatory agencies, and external stakeholders. The successful candidate will be a highly collaborative partner with a focus on scientific rigor, operational excellence, and advancing program objectives in a dynamic small biotech environment.
Key Responsibilities:
- Apply pharmacology expertise to evaluate mechanism of action, target engagement, exposure-response relationships, and dose selection strategies across development programs, including inhalation programs and respiratory models.
- Design and execute translational research strategies that connect nonclinical findings to clinical hypotheses for inhaled anti-fibrotic therapeutics.
- Lead the planning, oversight, and interpretation of nonclinical studies designed internally and conducted through CRO partners, ensuring alignment with program objectives, timelines, and regulatory expectations.
- Contribute to the development and oversight of nonclinical and clinical bioanalysis strategies and activities, as appropriate.
- Identify and qualify translatable biomarkers that can be deployed in early clinical trials to assess target engagement and disease modification.
- Partner with CMC, Clinical Pharmacology, Regulatory, and Biostatistics to integrate translational data into IND-enabling packages and clinical study design.
- Author, review, and provide strategic input to regulatory documents, including IND submissions, investigator brochures, briefing documents, nonclinical overviews, and clinical development plans, applying strong scientific writing and communication skills.
- Monitor external scientific and competitive landscapes to identify emerging opportunities, technologies, and development strategies relevant to respiratory diseases and broader portfolio objectives.
- Evaluate nonclinical and clinical data to identify opportunities, risks, and key development decisions across the portfolio.
- Present data and strategies at internal team meetings and external scientific conferences.
Qualifications:
- 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.
- Strong scientific communication skills; able to distill complex data for cross-functional audiences.
- Collaborative and team-oriented with the ability to thrive in a fast-paced, small company environment.
