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 actionable development decisions.
Responsibilities:
Clinical Development Strategy & Program Leadership
- Provide clinical and scientific expertise for Avalyn IPF/ILD programs and contribute to broader portfolio and development strategy.
- Develop and refine clinical trial strategies, including study sequencing, objectives, endpoints, patient populations, and overall program design.
- Lead cross-functional development discussions and evaluate program risks, opportunities, and development alternatives to inform study design, sequencing, and resource priorities.
- Provide strategic clinical input into development plans, target product profiles, and key program milestones.
Study Design & Clinical Trial Leadership
- Lead protocol development, including study objectives, endpoints, eligibility criteria, safety monitoring, and risk mitigation.
- Provide clinical and scientific leadership across multiple studies, ensuring consistency and scientific rigor across the development program.
- Contribute to statistical analysis plan assumptions and assess the clinical relevance and interpretability of statistical approaches.
- Provide clinical oversight into study feasibility, investigator/site selection, protocol amendments, and study-level development decisions.
- Partner with Clinical Operations and CROs to support effective study execution while maintaining scientific integrity and patient safety.
Medical Oversight, Safety & Data Interpretation
- Serve as an IPF/ILD disease-area expert and provide medical guidance across assigned programs.
- Provide medical oversight to study teams and Medical Monitors, including assessment of patient safety, clinical risk, and disease-specific considerations.
- Lead clinical data reviews and interpret emerging safety and efficacy data across studies.
- Identify cross-study trends and translate findings into clinical and development recommendations.
- Partner with Biostatistics, Data Management, Pharmacovigilance, and Translational Science on data review, interpretation, and benefit-risk assessment.
Clinical Documentation & Regulatory
- Provide clinical and scientific leadership in the development and review of protocols, Investigator Brochures, Clinical Study Reports, briefing documents, and regulatory submissions.
- Lead Clinical Study Report (CSR) authoring and ensure appropriate clinical interpretation of study findings.
- Support FDA and other health authority interactions, including EOP2 meetings and responses to regulatory questions.
- Contribute to regulatory strategy and translate clinical data and program strategy into clear, scientifically rigorous regulatory narratives.
Cross-Functional & External Leadership
- Serve as a senior clinical leader on multidisciplinary development teams and provide clear recommendations to senior leadership.
- Build strong relationships with investigators, KOLs, external experts, CROs, and other external partners.
- Provide clinical and scientific leadership at investigator meetings, advisory boards, and other external forums.
- Support identification and engagement of clinical experts and investigators to inform program strategy and trial design.
Scientific Communications
- Contribute to publication strategy and external dissemination of clinical development data.
- Lead or support abstracts, posters, manuscripts, presentations, and scientific publications.
- Present clinical development strategy and emerging data at investigator meetings, advisory boards, scientific congresses, and other external forums.
- Maintain awareness of evolving IPF/ILD literature, treatment paradigms, competitive developments, and standards of care.
Qualifications:
- Advanced clinical or scientific degree (e.g., DNP, APRN, MD, PhD or equivalent) with significant clinical research, clinical development, or relevant therapeutic-area experience.
- 7–10+ years of experience in 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
