Backed by Norwest.
About the role
The Senior Director, Clinical Safety Physician provides medical leadership and oversight of drug safety across Avalyn’s portfolio of inhaled antifibrotic investigational products. The role is accountable for the ongoing medical evaluation, surveillance, interpretation, documentation, and communication of emerging safety data, including adverse event assessment, signal detection, and characterization of potential risks, ensuring that safety findings are appropriately incorporated into clinical development and risk... Found on 1752vc Careers, the job board for startup and VC roles.
What they're looking for
- MD or DO required, board certification or equivalent clinical specialty qualification preferred
- Strong working knowledge of applicable ICH safety guidelines, GCP, MedDRA, and applicable US and international investigational product safety-reporting requirements
- Experience interacting with FDA and/or other global regulatory authorities on safety matters is a plus
- Experience overseeing and managing outsourced PV organizations and CROs is preferred
- Applies strong clinical judgment to distinguish potential drug-related safety findings from underlying disease, concomitant illnesses, and background events
- Interprets emerging safety trends across doses, exposure, duration, and patient populations, translating findings into recommendations affecting trial design, monitoring, and development strategy
More about this role
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...
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