Director, Clinical Operations

Benefits

Additional Information

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