Company Overview:

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 lead program, 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 its second program, AP02, inhaled nintedanib, for the treatment of idiopathic pulmonary fibrosis (IPF). For more information, please visit avalynpharma.com and follow us on LinkedIn.

Position Overview:
The Vice President of Clinical Operations is a strategic leadership role responsible for overseeing and directing the global clinical operations department. This executive position plays a critical role in the successful planning, execution, and oversight of Avalyn’s clinical trials and studies across all phases, ensuring operational excellence, regulatory compliance, and alignment with organizational goals. The VP will lead a high-performing team of clinical operations professionals, fostering a culture of innovation, collaboration, and continuous improvement. This role reports directly to the SVP, Clinical Development Operations.

Key Responsibilities:

• Strategic Leadership: Develop and execute a comprehensive strategic vision for the clinical operations department, ensuring alignment with Avalyn’s broader organizational objectives. Provide leadership, guidance, and mentorship to the clinical operations leadership team, fostering a high-performance culture.

• Department Oversight: Lead the planning, initiation, execution, and closure of all clinical trials globally, including complex, early-phase, and late-phase studies. Ensure seamless coordination across functional areas including medical affairs, regulatory, data management, biostatistics, and outside vendors.

• Resource and Budget Management: Oversee departmental resource planning, including budget allocation, staffing, and infrastructure. Optimize resource utilization to maximize operational efficiency, cost-effectiveness, and quality.

• Regulatory and Quality Compliance: Ensure all clinical operations adhere to relevant regulations (FDA, EMA, ICH-GCP) and internal quality standards. Drive continuous improvement in quality systems, audit readiness, and operational compliance.

• Vendor and Partner Management: Establish and maintain strategic relationships with external vendors, CROs, laboratories, and other service providers. Negotiate contracts, oversee vendor performance, and ensure deliverables meet timelines, budget, and quality standards.

• Risk Management: Identify potential risks in clinical trial execution, including data integrity, patient safety, and protocol adherence. Develop and implement mitigation strategies and contingency plans to address issues proactively.

• Leadership Development: Build and lead a robust, motivated clinical operations team. Implement leadership development initiatives, enhance team capabilities, and foster a collaborative, innovative, and patient-centric work environment.

• Stakeholder Engagement: Collaborate closely with internal stakeholders (Senior Leadership, Clinical Development, Medical Affairs, Regulatory) and external partners to align clinical operations with organizational strategy. Represent the department in executive meetings and strategic planning.

• Data and Performance Analytics: Oversee the use of data, KPIs, and metrics to monitor trial progress, quality, and operational performance. Leverage insights to drive continuous process improvements and strategic adjustments.

Qualifications and Requirements:

• Advanced degree in life sciences, medicine, pharmacy, or a related field; Ph.D., M.D., or equivalent preferred.

• 15+ years of progressive leadership experience in clinical operations within the pharmaceutical, biotech, or healthcare industry, with a proven track record in managing large, global clinical trial programs.

• Extensive experience managing a department or function, including leading large teams and cross-functional groups.

• Deep knowledge of regulatory requirements (FDA, EMA, ICH-GCP), clinical trial conduct, and GXP standards.

• Demonstrated success in vendor management, contract negotiations, and strategic partnering.

• Strong financial acumen, with experience managing departmental budgets and resource planning.

• Excellent leadership, strategic thinking, and decision-making skills, with the ability to influence and motivate at all levels.

• Exceptional communication, interpersonal, and stakeholder management capabilities.

• Experience with clinical trial technology and data systems is advantageous.

• Previous experience in rare diseases or respiratory therapeutics is preferred but not mandatory.