Director, Clinical Development Research Scientist

The posting, as Avalyn Pharma wrote it

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 Summary

The Director, Clinical Development Research Scientist will report to the Senior Vice President, Clinical Development and serve as a key clinical and scientific leader advancing Avalyn’s IPF/ILD clinical development programs. This individual will provide therapeutic-area expertise and strategic leadership across the development lifecycle, from program and study strategy through protocol design, clinical execution, data interpretation, regulatory interactions, and development planning.

The Director will lead one or more clinical trials and partner closely with Clinical Operations, Biostatistics, Regulatory Affairs, Pharmacovigilance, Translational Science, Data Management, CMC, and other functions to ensure clinical trial activities are scientifically rigorous, patient-focused, operationally feasible, and aligned with broader program objectives.

This individual will help shape development strategy, including study design, endpoints, development sequencing, risk assessment, data interpretation, and program-level decision-making. The Director will also provide medical and scientific expertise across multiple studies, serve as a resource to investigators and external experts, and contribute to regulatory interactions, advisory boards, publications, and scientific presentations.

The successful candidate will bring a balance of strategic thinking and hands-on clinical development expertise, with the ability to translate emerging clinical data into actionabl
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n clinical research, clinical development, drug development, or a related field, including meaningful sponsor-side experience.

• Deep expertise in IPF, ILD, or pulmonary medicine, , with a strong understanding of the treatment landscape and unmet patient needs.
• Demonstrated experience leading or contributing to Phase 2 and/or Phase 3 clinical trials, including strong experience in protocol development, clinical trial strategy, safety monitoring, and risk mitigation.
• Demonstrated ability to interpret clinical safety and efficacy data and translate findings into evidence-based, program-level development decisions.
• Experience contributing to clinical development strategy across multiple studies and/or development stages, with the ability to connect study-level decisions to broader program, portfolio, and product objectives.
• Working knowledge of ICH-GCP and global regulatory requirements, with experience supporting health authority interactions and clinical/regulatory documentation.
• Demonstrated experience managing, mentoring, and developing clinical development professionals, with strong leadership and influencing skills and the ability to build high-performing teams.
• Excellent communication and collaboration skills, with the ability to engage effectively with investigators, KOLs, regulatory agencies, senior leadership, and cross-functional stakeholders.
• Strong scientific and clinical judgment, with the ability to evaluate benefit-risk considerations, make clear recommendations, and influence decisions across the organization.
• Ability to operate effectively in a fast-paced environment while balancing strategic responsibilities with hands-on clinical development activities.
• Willingness to travel as needed for investigator meetings, advisory boards, site visits, scientific conferences, and other clinical development activities.
• Ability and willingness to travel up to 25% domestic and international

Proposed pay range
$220,000 — $242,000 USD