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

The Associate Director of SEC Reporting & Technical Accounting will build and lead Avalyn’s external reporting and SOX compliance capabilities as a newly public biotechnology company. This high-impact, foundational position is ideal for a technically strong, pragmatic leader who enjoys creating structure in a dynamic, mission-driven environment. The Director will establish scalable SEC reporting processes, design and document internal controls over financial reporting, and serve as the Company’s subject matter expert on complex accounting matters. Reporting to the VP of Finance, this role partners closely with Finance and cross-functional teams across the organization to drive alignment, accountability, and best practices through strong collaboration and clear communication.

SEC Reporting

• Lead the preparation and timely filing of SEC reports, including Forms 10-K, 10-Q, 8-K, and S-8, and oversee XBRL tagging and related external reporting processes.
• Own the preparation and review of financial statements, footnotes, and MD&A, ensuring compliance with U.S. GAAP and SEC regulations.
• Partner with Legal, FP&A, Investor Relations, and senior leadership on earnings releases, proxy materials, and other public disclosures.

Technical Accounting

• Serve as the company’s subject matter expert on technical accounting matters, including revenue recognition, collaboration and licensing arrangements, R&D activities, financing transactions, and stock-based compensation under ASC 718.
• Research, evaluate, and document accounting conclusions for complex transactions and prepare technical accounting memoranda and policy documentation.
• Support commercialization readiness by helping establish GAAP- and SOX-compliant revenue accounting and order-to-cash processes in partnership with Commercial, Market Access, Finance, and IT.

SOX Compliance & Internal Controls

• Design and implement internal controls over financial reporting as the company continues to build toward full SOX compliance.
• Lead walkthroughs, risk assessments, control documentation, and remediation efforts in partnership with process owners and external consultants.
• Strengthen scalable controls and operating processes across SEC reporting, technical accounting, and equity administration.

Equity Accounting & Administration

• Lead equity accounting, including the calculation and recording of stock-based compensation in accordance with ASC 718.
• Oversee external support for day-to-day stock administration activities and help ensure strong governance around equity-related processes.
• Support Section 16 reporting and related compliance requirements in coordination with legal counsel.

External Audits

• Manage quarterly reviews and annual audits and serve as the primary liaison with external auditors on technical accounting matters.
• Coordinate PBC requests and support an efficient, well-organized audit process.

Qualifications

• A minimum of a Bachelor’s degree in Accounting or Finance required; CPA required.
• 8-10+ years of progressive accounting experience, including substantial SEC reporting and technical accounting experience in a public company environment.
• Big 4 or national public accounting firm experience strongly preferred.
• Demonstrated experience building or enhancing SOX compliance programs.
• Experience in biotechnology, life sciences, or other R&D-intensive industries strongly preferred; experience with cell therapy revenue recognition is a plus.
• Deep knowledge of U.S. GAAP and SEC regulations, including revenue recognition, equity compensation, and complex transaction accounting.
• Experience with tools such as Active Disclosure, Equity Edge, NetSuite, or similar systems preferred.
• Strong communication, sound judgment, and the ability to lead through influence in a fast-paced, mission-driven environment.

Company Summary

Avalyn is reimagining the future of pulmonary fibrosis treatment with a pipeline of new inhaled formulations of approved medicines designed to reduce systemic exposure and deliver medication directly to the site of disease. Pulmonary fibrosis is characterized by scarring of lung tissue, decline in lung function, and reduced exercise capacity and quality of life, and is associated with increased mortality. Currently approved therapeutic options slow pulmonary fibrosis progression but are associated with significant toxicities that restrict their use and dosing. Avalyn’s inhaled approach tackles the underlying pathophysiology of pulmonary fibrosis at its source and is designed to reduce systemic exposure and deliver medication directly to the site of disease. Avalyn’s AP01 is an optimized inhaled formulation of pirfenidone, currently being studied in the ongoing MIST Phase 2b study in progressive pulmonary fibrosis (PPF). AP01 has been assessed in over 150 individuals with different forms of pulmonary fibrosis and demonstrated clinical proof-of-concept with improved efficacy and safety compared to historical data with existing therapies. The company completed two Phase 1 studies for AP02, inhaled nintedanib, for the treatment of idiopathic pulmonary fibrosis (IPF) and is planning a Phase 2 clinical trial. For more information, please visit avalynpharma.com and follow us on LinkedIn.

Position Summary

The Director of Clinical Operations is a senior-level position responsible for overseeing and managing the clinical operations of assigned clinical trials or program of trials. This role plays a critical role in ensuring the successful planning, execution, and monitoring of Avalyn’s global clinical trials and studies. This position will report to the VP of Clinical Operations and can be remote-based anywhere in the United States.

Key Responsibilities (at the study or program level):

• Strategic Leadership: Develop and implement the operations plans and logistics for their assigned study or program of studies aligning with the organization's goals and objectives. Provide leadership and guidance to the clinical operations team, ensuring the successful execution of clinical programs.
• Clinical Trial Management: Oversee the planning, initiation, execution, and completion of clinical trials in accordance with applicable regulations, guidelines, and standard operating procedures (SOPs). Coordinate with cross-functional teams, including outside vendors, medical affairs, regulatory affairs, data management, and biostatistics, to ensure seamless trial execution.
• Resource Management: Indirectly manage external providers’ study or program level resources to support clinical operations. Directly manage internal resources who support the Director’s assigned studies or program level of studies.  Monitor resource utilization and implement strategies to optimize efficiency and productivity.
• Quality Assurance: Ensure compliance with relevant regulatory requirements, Good Clinical Practice (GCP) guidelines, and internal Standard Operating Procedures (SOPs), and other related quality standards. Work directly with the Avalyn Quality Management function to develop and maintain quality management systems to monitor and improve the quality of clinical operations processes.
• Strategic Partner/Vendor Management: Oversee the selection, evaluation, and management of external partners/vendors, such as contract research organizations (CROs), central laboratories, and other service providers. Establish strong relationships with partners/vendors and negotiate contracts to ensure cost-effectiveness and high-quality deliverables.
• Risk Management: Identify and mitigate risks associated with clinical trials, including protocol deviations, adverse events, and data integrity issues. Implement risk management strategies and develop contingency plans to address potential challenges and ensure patient safety.
• Sponsor Oversight and Clinical Trial Management: Develop and implement clinical trial monitoring standards and best practices for effective monitoring of investigational sites and the overall quality and integrity of each assigned clinical trial or program of trials, in accordance with industry standards and practices.
• Team Development: Operate as “one team” through clear and transparent communications and appropriate team building strategies. Provide mentoring, coaching, and performance feedback to enhance individual and team capabilities. Foster a culture of collaboration, innovation, and continuous improvement.
• Stakeholder Engagement: Collaborate with internal stakeholders, such as senior management, clinical development teams, Key External Experts, and regulatory affairs, to align clinical operations strategies with broader organizational objectives. Establish strong relationships with external stakeholders, including investigators, study sites, and regulatory authorities.
• Data Management and Analysis: Working internally/externally with data operations experts to understand the data collection, analysis, and interpretation of clinical trial data.
• Business Process Improvement: Contribute to the identification of business process improvement needs or opportunities, and lead or participate in strategic and continuous business improvement initiatives in study planning & set up, study conduct & close out, vendor and CRO selection and management, budget development & management, and other initiatives to support Avalyn clinical development needs.
• Personnel Management: Provide direct or indirect line management of clinical operations staff contract or consultant staff on an as-needed basis. Mentor and coach CO and other functional department team members on clinical trial operations.  If in a formal line management role, conduct appropriately timed performance reviews, calibration sessions, and feedback discussions.  Perform competency assessments and suggest approaches to address identified developmental opportunities.
• Collaborate with the VP, Clinical Operations and colleagues from other functional groups with responsibilities in the therapeutic program (Clinical Development, Medical Affairs, Regulatory Affairs, Data Management, Finance, and Program Management) to ensure alignment of resources and tasks management to meet Avalyn business needs and to achieve Avalyn corporate goals.

Qualifications and Requirements:

• Degree required with a degree in life sciences, medicine, pharmacy, or a related field preferred. A Ph.D., M.D., or equivalent is appreciated but not required.
• Extensive experience (typically 10+ years) in clinical operations within the healthcare or pharmaceutical industry, including significant experience in clinical trial management.
• Experience in rare diseases and respiratory diseases/research highly preferred.
• Strong working knowledge of applicable regulatory guidelines and requirements (e.g., FDA, EMA), as well as ICH-GCP and other relevant industry standards.
• Proven leadership and management skills, with the ability to lead and motivate cross-functional teams.
• Excellent organizational, planning, and project management abilities, with the capacity to handle multiple priorities and meet tight deadlines or successfully negotiate modifications.
• Strong problem-solving and decision-making skills, with a focus on driving inspection readiness, continuous improvement, and operational excellence.
• Demonstrated successful experience managing/overseeing Contract Research Organizations (CROs), vendors and other 3^rd party suppliers
• Experience working across all phases of clinical development (Phases I – III; phase IV experience helpful)
• Working medical and scientific knowledge; experience in the Respiratory Therapeutic Area strongly desirable
• Prior experience as Clinical Research Associate (CRA/monitor), Lead CRA, or Project Manager at either Sponsor, CRO helpful but not required
• Excellent communication and interpersonal skills, with the ability to effectively collaborate with internal and external stakeholders at all levels.
• Experience in vendor management and contract negotiation is desirable.
• Familiarity with clinical trial technology and data management systems is an advantage.

Business Requirements:

• Limited business travel domestically and internationally may be required.
• Fully remote position.
• Ability to communicate in English (written and verbal). Fluency to read or speak other languages is beneficial.