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Director of Clinical Operations

Avalyn PharmaBoston, MA
Remote Full-time $215K/yr - $230K/yr

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Experience Level

Senior Level Manager

Qualifications

Position Summary The Director of Clinical Operations is a pivotal senior-level role responsible for overseeing the clinical operations of assigned clinical trials or a program of trials. This key position is essential for the successful planning, execution, and monitoring of Avalyn’s global clinical studies. The Director will report directly to the VP of Clinical Operations and has the flexibility to work remotely from anywhere in the United States. Key Responsibilities: Strategic Leadership: Develop and implement operational plans and logistical strategies for assigned studies, ensuring alignment with the organization’s overarching goals. Provide strong leadership and mentorship to the clinical operations team to guarantee effective execution of clinical programs. Clinical Trial Management: Direct and oversee the comprehensive planning, initiation, execution, and completion of clinical trials in compliance with regulatory requirements and company standards.

About the job

Avalyn Pharma is innovating the landscape of pulmonary fibrosis treatment through a groundbreaking pipeline of inhaled formulations. These approved medications are expertly designed to minimize systemic exposure and deliver targeted therapy directly to the affected areas. Pulmonary fibrosis, characterized by lung tissue scarring, diminishes lung function and quality of life, contributing to increased mortality rates. Conventional therapeutic options may slow disease progression but often come with significant toxicities that limit their application. Avalyn’s inhaled approach directly addresses the underlying causes of pulmonary fibrosis, aiming to enhance patient outcomes with reduced systemic side effects. Currently, Avalyn’s AP01, an optimized inhaled formulation of pirfenidone, is under investigation in the MIST Phase 2b study for progressive pulmonary fibrosis (PPF). This formulation has demonstrated clinical proof-of-concept with better efficacy and safety profiles compared to existing treatments, having been evaluated in over 150 patients with various forms of pulmonary fibrosis. Furthermore, Avalyn has completed two Phase 1 studies for AP02, an inhaled formulation of nintedanib for idiopathic pulmonary fibrosis (IPF), with plans for a Phase 2 clinical trial in the works. For more details, please visit avalynpharma.com and follow us on LinkedIn.

About Avalyn Pharma

Avalyn Pharma is at the forefront of innovation in pulmonary fibrosis treatment, focusing on advanced inhaled therapies that prioritize patient safety and efficacy. With a commitment to enhancing the quality of life for individuals suffering from pulmonary fibrosis, Avalyn leverages cutting-edge science and research to deliver targeted therapies that address the disease at its core.

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