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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-IPF, 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 Overview:  

Reporting to the VP, Program Management, the Director/Sr. Director, Program Management, will provide project and program leadership to cross-functional teams, driving the planning, execution, and delivery of Avalyn's pipeline assets from preclinical development through commercialization in alignment with company strategy. They will lead and provide cross-functional oversight for multiple programs based on business needs and organizational priorities. In this capacity, they will serve as a partner to Program Leads and functional leaders, helping shape program strategy, evaluate development scenarios, identify and mitigate risks, and drive execution across all phases of development. This individual will help establish and maintain project management best practices, templates, tools, and processes (e.g. budget, risk, and timeline management) to ensure consistency across programs. This role requires a leader who can operate effectively at both the strategic and tactical levels while ensuring effective governance and cross-functional alignment. The ideal candidate will bring strong judgment and executive presence to influence and drive key decisions, helping Avalyn achieve its mission of delivering life-changing therapies for patients with unmet needs. 

Key Responsibilities

• Partner closely with Program Leads and functional leaders to drive cross-functional alignment and execution of development programs from early development through clinical execution and commercialization. 
• Lead integrated program planning and execution, including development strategy, clinical development plans, timelines, budgets, resource planning, risk management, and scenario planning. 
• Provide program leadership and oversight for multiple R&D programs, balancing strategic priorities, resource planning, risk management, and execution across the portfolio.
• Direct and coordinate cross-functional teams (clinical, regulatory, CMC, manufacturing, commercial, statistics, preclinical) to deliver programs on time and within budget.
• Identify critical path activities, anticipate risks and opportunities, develop mitigation strategies, and facilitate timely decision-making through team and governance forums.
• Monitor program performance, prepare and deliver clear, concise program updates, recommendations, dashboards, and decision packages for governance committees and senior leadership.
• Facilitate cross-functional meetings, drive accountability, and ensure timely resolution of actions and challenges.
• Develop and present program scenarios, risks, timelines, costs, and strategic options to support executive decision-making.
• Lead problem-solving, contingency planning, and issue resolution for complex development challenges.
• Partner with the VP, Program Management and other team members as needed, championing program management best practices, governance standards, process improvements, and organizational effectiveness.

Key Qualifications

• A minimum of a Bachelor's degree is required; Advanced degree (MS, PhD, PharmD or equivalent) preferred. Requires a Bachelor's degree with 12+ years of relevant biotechnology, pharmaceutical, or related industry experience, a Master's degree with 10+ years of experience, or a PhD/PharmD with 8+ years of experience.
• 5-10+ years of progressive hands-on R&D Project/Program Management experience in biotech, pharmaceutical, or related industry, including experience in leadership of cross-functional development programs; Level commensurate with experience.
• Demonstrated experience supporting programs from early development through late-stage clinical development, registration, launch preparation, and/or commercialization.
• Experience within respiratory disease, pulmonary medicine, rare disease, oncology, or other specialty therapeutic areas preferred. Experience in pulmonary fibrosis, drug-device combination products, and/or inhaled therapeutics (INH) is highly desirable but not required.
• Deep understanding of clinical development plans, clinical trial execution, drug development, regulatory requirements, with a focus on patient-centered drug development is essential.
• Demonstrated ability to collaborate and lead with executive presence, positively influence performance excellence, and encourage innovation across all therapeutic areas and levels.
• Experience working cross-functionally with internal stakeholders including clinical development teams, CMC, finance, medical affairs, portfolio management, and communications/corporate affairs.
• PMP or similar project management certification is desirable.
• Strong organizational and time-management skills, with the ability to manage multiple complex programs simultaneously, proactively identify and mitigate risks, and drive execution with urgency to achieve critical development and business objectives is essential.
• Proficiencyin project management tools (e.g.,Microsoft Timeline, Smartsheet) and collaboration platforms.
• Strong oral and written communication skills are essential, including the ability to influence and drive performance at all levels of the organization.
• Self-motivated, independent, and able to work effectively in a small team and fast-paced environment.
• Ability and willingness to travel ~15% for meetings as needed.