Director of Clinical Operations

Director of Clinical Operations

Company Overview:

Avalyn Pharma is developing innovative, targeted inhaled therapies for rare respiratory diseases, including idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF). Avalyn completed an oversubscribed $175M Series C financing in September 2023 to advance our clinical-stage pulmonary fibrosis portfolio consisting of inhaled pirfenidone (AP01), inhaled nintedanib (AP02), and a fixed-dose combination of both (AP03). Currently, treatment for IPF and PPF includes oral antifibrotics, pirfenidone and nintedanib. Due to side effects, 30-50% of patients cannot tolerate these medications. Avalyn has developed inhaled formulations for these FDA-approved antifibrotics. AP01 has now been studied in over 150 patients with various forms of pulmonary fibrosis, over at least 48 weeks and some out to 4 years and is phase 2b ready. PK studies show that AP01 reaches thirty-five times the concentration in the lung with 1/15th of the systemic concentration compared to historic oral pirfenidone. AP01 has demonstrated efficacy, with a high dose achieving near stabilization of lung function and is well tolerated with fewer systemic adverse events vs. historic oral pirfenidone. We have also completed our a phase 1a study of AP02, an inhaled formulation of nintedanib, with phase 1b & 2 plans being developed. Phase 1a positive topline results were announced in March 2023, and AP02 was demonstrated to be safe and well tolerated in normal volunteers & IPF patients.

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 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.