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 Overview:

Avalyn Pharma is seeking a highly motivated and experienced Director, CMC Project Management to plan and lead cross-functional Chemistry, Manufacturing, and Controls (CMC) project activities across Avalyn’s development-portfolio, overseeing the successful delivery of Avalyn’s development projects. Reporting to the SVP of Product Development, this individual will play a critical role in driving execution of CMC strategy, ensuring alignment across internal teams, external partners, and maintain CMC development timelines. This is a high-impact role requiring strong program management skills, technical CMC knowledge, medical device experience and the ability to operate effectively in a fast-paced, matrixed biotech environment.

Key Responsibilities:

• Together with the SVP PD, develop, maintain, and track detailed CMC project plans, timelines, and deliverables across various workstreams in CMC (e.g., drug substance, drug product, device, analytical, and packaging/labeling/distribution).
• In collaboration with the SVP Product Development, the ideal candidate will drive cross-functional planning and execution of CMC activities, ensuring alignment with Avalyn’s overall product development and corporate objectives, in close partnership with Product Development, Quality, Regulatory Affairs, Clinical Operations, Finance and Program Management.
• Facilitate routine CMC team meetings and cross-functional discussions; prepare agendas, track action items, and promote timely resolution of issues to keep programs on schedule.
• Communicate project status, progress, and potential issues to key stakeholders, including senior management and external partners
• Partner with external vendors and contract manufacturing organizations (CMOs) to manage timelines, deliverables, and quality expectations; ensure integration of external workstreams into overall program plans.
• Support preparation and submission of high-quality CMC documentation for global regulatory filings, including INDs, IMPDs, and NDAs.
• Proactively identify project risks and mitigation strategies; escalate critical issues to leadership with recommended solutions.
• Collaborate with Portfolio Management, Program Management, Finance and functional leads to support scenario planning, resource allocation, and budgeting for CMC activities.
• Provide clear, concise updates to senior leadership on progress, key decisions, and risks affecting development timelines and milestones.

Key for this role are:

• Bachelor’s degree in life sciences, chemistry, pharmaceutical sciences, engineering, or related field. A PhD or Master degree is preferred.
• Minimum of 10 years of experience in Project Management or related roles in the biotech, pharmaceutical, or healthcare industries. Preferred in publicly traded life science and/or biotech companies.
• Minimum of 5 years of experience in CMC project management role.
• PMP or similar project management certification preferred.
• Demonstrated success managing complex CMC programs from early through late clinical phases, including global submissions.
• Experience working with drug-device combination products and/or inhalation therapies is highly desirable.
• Proven experience working with rare diseases or respiratory conditions is a strong plus.
• Deep understanding of drug and device development, CMC disciplines and regulatory requirements, with a focus on patient-centered drug development.
• Proficiency in project management tools (e.g., Microsoft Project, Smartsheet) and collaboration platforms.
• Excellent communication, organization, and interpersonal skills; able to influence and lead without direct authority.
• Willingness and able to travel domestically and internationally as needed for meeting with external vendors and team.
• Self-motivated, independent, and able to work effectively in a small team and fast-paced environment
• Strong organizational and time-management skills, with the ability to prioritize and manage multiple projects simultaneously