Director, IPF/ILD Clinical Development

Avalyn Pharma; United States; On-site; USD 220,000 - 240,000; Full time

Job summary

Avalyn Pharma is seeking a Director, Clinical Development to oversee IPF/ILD programs with a focus on patient safety, scientific integrity, and regulatory readiness. You will lead protocol design, safety monitoring, study execution, and global collaborations across functions.

Reporting to SVP Clinical Development, you will drive medical strategy for trials, review emerging data, contribute to CSR and regulatory submissions, and engage health authorities and investigators to advance Avalyn’s

Qualifications

• 5-7+ years in IPF/ILD clinical care, research, or drug development.
• 3-5+ years in clinical development, with Phase 2-3 experience, preferably global.
• Therapeutic expertise in IPF/ILD or related respiratory disease.
• Experience in protocol development, endpoints, safety monitoring, and risk mitigation.
• Strong clinical judgment, patient safety focus, and ability to interpret safety data.
• Knowledge of ICH-GCP and global regulatory requirements; experience with health authority interactions.
• Proven ability to lead cross-functional teams and communicate effectively.

Responsibilities

• Lead study design and protocol development, including endpoints and criteria.
• Define medical monitoring, safety plans, and risk mitigation with the Medical Monitor.
• Provide cross-functional leadership across Clinical Operations, Biostatistics, Regulatory, PV, Translational Science, and CROs.
• Co-lead blinded data review and interpret safety/efficacy data for CTRs.
• Lead CSR development and coordinate medical writer responsibilities.
• Support regulatory agency interactions, advisory boards, and publications.

Skills

IPF/ILD clinical care

Clinical development leadership

Cross-functional collaboration

Safety monitoring & risk mitigation

Regulatory interactions

Excellent communication

Education

Advanced clinical or scientific degree (APR N/RRT/PharmD/PhD)

Job description

Avalyn Pharma is seeking a Director, Clinical Development to oversee IPF/ILD programs with a focus on patient safety, scientific integrity, and regulatory readiness. You will lead protocol design, safety monitoring, study execution, and global collaborations across functions.

Reporting to SVP Clinical Development, you will drive medical strategy for trials, review emerging data, contribute to CSR and regulatory submissions, and engage health authorities and investigators to advance Avalyn’s