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 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. The Director, Clinical Development serves as the primary medical leader for assigned trials, with a strong focus on patient safety, scientific integrity, and clinical relevance.
The Director, Clinical Development works cross-functionally with Clinical Operations, Biostatistics, Regulatory Affairs, Pharmacovigilance, Translational Science, Data Management, and external CROs to support effective trial execution and alignment with overall program strategy. This individual provides medical direction on protocol design, safety monitoring, risk mitigation, data review, and clinical trial amendments, while serving as a key medical resource for investigators and study teams.
The role also leads medical review and interpretation of emerging safety and efficacy data, contributes to Clinical Study Reports and regulatory submissions, and supports health authority interactions, advisory boards, investigator meetings, publications, and scientific presentations.
Responsibilities:
Study Design & Strategy
- Lead clinical trial strategy and protocol development, including endpoints, inclusion/exclusion criteria, and clinical trial design.
- Define medical monitoring, safety, and risk mitigation strategies in partnership with the Medical Monitor.
- Contribute to statistical analysis plan assumptions and the clinical relevance of the statistical design.
- Support site identification and selection based on disease-area expertise.
- Provide medical input for clinical trial amendments and study-specific regulatory interactions.
Medical Monitoring & Safety
- Serve as the disease-state expert and provide medical guidance to the Medical Monitor and clinical trial team.
- Review SAEs, SUSARs, safety signals, eligibility deviations, protocol exceptions, and violations with appropriate stakeholders.
- Support development of DSMB and Safety Review Committee materials.
- Ensure clinical trial conduct meets GCP and patient safety standards.
Cross-Functional Leadership
- Serve as the medical leader for the clinical trial team, partnering closely with Clinical Operations, Biostatistics, Regulatory Affairs, Pharmacovigilance, Translational Science, and external CROs.
- Provide medical guidance to site investigators and resolve clinical or disease-related questions.
- Ensure study conduct remains aligned with overall program strategy.
- Conduct site visits as appropriate to maintain engagement with investigators and study teams.
Data Review & Interpretation
- Co-lead blinded data review meetings and interpret emerging safety and efficacy data.
- Lead medical interpretation of safety and efficacy outcomes for Clinical Trial Reports (CTRs) and support interim analyses and futility assessments.
Clinical Study Report
- Lead the development and authoring of the Clinical Study Report (CSR), including identifying the medical writer and assigning section responsibilities.
Regulatory & External Activities
- Participate in study-specific regulatory agency interactions and co-lead development of EOP2 materials with Regulatory Affairs.
- Respond to health authority questions related to the study.
- Present clinical data at advisory boards and investigator meetings and support publications and congress presentations.
Qualifications:
- 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.
- Working knowledge of ICH-GCP, clinical research standards, and global regulatory requirements, with experience supporting health authority interactions.
- Proven ability to lead and influence cross-functional teams and collaborate effectively with Clinical Operations, Biostatistics, Regulatory Affairs, Pharmacovigilance, Translational Science, and external partners.
- Excellent written and verbal communication skills, with the ability to effectively engage investigators, clinical sites, CROs, regulatory agencies, and internal stakeholders.
- Strong strategic thinking and business judgment, with the ability to connect trial-level decisions to broader clinical development and program objectives.
- Ability to work effectively in a fast-paced, collaborative environment and balance strategic responsibilities with hands-on involvement in clinical trial execution.
