Senior Director, Clinical Safety Physician

The role

The Senior Director, Clinical Safety Physician provides medical leadership and oversight of drug safety across a portfolio of inhaled antifibrotic investigational products. This role involves evaluating emerging safety data, performing medical reviews of adverse events, and providing medical recommendations to inform clinical development and risk management decisions.

What you will do

• Provide medical leadership and oversight of safety across clinical-stage investigational products.
• Perform medical review and assessment of serious adverse events, deaths, and discontinuations.
• Review case narratives and ensure appropriate follow-up of medically important information.
• Identify, evaluate, and escalate potentially important safety findings.
• Provide ongoing safety oversight of Phase 1–3 clinical trials.
• Provide medical safety input into clinical trial design, protocols, and informed consent documents.
• Lead medical safety surveillance and proactively identify potential safety signals.
• Lead and maintain an evolving benefit-risk assessment for each investigational product.
• Lead medical review of Development Safety Update Reports and other periodic safety reports.
• Provide medical oversight of outsourced pharmacovigilance activities and PV vendors.

Required qualifications

• MD or DO required
• Minimum of 10+ years in pharmaceutical or biotechnology clinical development or drug safety
• Meaningful pharmacovigilance responsibility and experience providing medical safety oversight for interventional clinical trials
• Demonstrated experience reviewing serious adverse events (SAEs) and individual case safety reports (ICSRs)
• Experience reviewing and providing medical input into DSURs, IBs, clinical study protocols, and IND safety reporting
• Strong working knowledge of applicable ICH safety guidelines, GCP, MedDRA, and US and international investigational product safety-reporting requirements
• Willing and able to travel domestically and internationally up to 15%

Nice to have

• Board certification or equivalent clinical specialty qualification
• Experience in pulmonary diseases, particularly interstitial lung disease (ILD), idiopathic pulmonary fibrosis (IPF), or progressive pulmonary fibrosis (PPF)
• Experience in rare diseases or inhaled therapeutics
• Phase 2/3 development experience
• Experience interacting with FDA and/or other global regulatory authorities on safety matters
• Experience overseeing and managing outsourced PV organizations and CROs
• Experience operating within a public-company governance structure

About the company

Avalyn aims to transform the treatment paradigm for pulmonary fibrosis and other serious, rare respiratory diseases through optimized inhaled formulations. The company is advancing several programs, including AP01, AP02, and AP03, using a proprietary drug-device approach.