Director/Sr. Director, Program Management

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Avalyn Pharma

WebsiteLinkedInAll Job Openings

11 - 50 employees

🧬 Biotechnology

⚕️ Healthcare Insurance

💊 Pharmaceuticals

Biotechnology • Healthcare Insurance • Pharmaceuticals

Avalyn Pharma is a biopharma company dedicated to developing innovative medicines aimed at treating rare lung diseases. The company is currently conducting the MIST Study, a Phase 2b clinical trial assessing the safety and efficacy of an inhaled version of pirfenidone, known as AP01, for patients diagnosed with Progressive Pulmonary Fibrosis (PPF). Through their research, Avalyn Pharma seeks to improve lung function and the overall quality of life for individuals suffering from this serious condition.

📋 Description

• Partner closely with Program Leads and functional leaders to drive cross-functional alignment and execution of development programs from early development through clinical execution and commercialization. • Lead integrated program planning and execution, including development strategy, clinical development plans, timelines, budgets, resource planning, risk management, and scenario planning. • Provide program leadership and oversight for multiple R&D programs, balancing strategic priorities, resource planning, risk management, and execution across the portfolio. • Direct and coordinate cross-functional teams (clinical, regulatory, CMC, manufacturing, commercial, statistics, preclinical) to deliver programs on time and within budget. • Identify critical path activities, anticipate risks and opportunities, develop mitigation strategies, and facilitate timely decision-making through team and governance forums. • Monitor program performance, prepare and deliver clear, concise program updates, recommendations, dashboards, and decision packages for governance committees and senior leadership. • Facilitate cross-functional meetings, drive accountability, and ensure timely resolution of actions and challenges. • Develop and present program scenarios, risks, timelines, costs, and strategic options to support executive decision-making. • Lead problem-solving, contingency planning, and issue resolution for complex development challenges. • Partner with the VP, Program Management and other team members as needed, championing program management best practices, governance standards, process improvements, and organizational effectiveness.

🎯 Requirements

• A minimum of a Bachelor’s degree is required; Advanced degree (MS, PhD, PharmD or equivalent) preferred. Requires a Bachelor's degree with 12+ years of relevant biotechnology, pharmaceutical, or related industry experience, a Master’s degree with 10+ years of experience, or a PhD/PharmD with 8+ years of experience. • 5–10+ years of progressive hands-on R&D Project/Program Management experience in biotech, pharmaceutical, or related industry, including experience in leadership of cross-functional development programs; Level commensurate with experience. • Demonstrated experience supporting programs from early development through late-stage clinical development, registration, launch preparation, and/or commercialization. • Experience within respiratory disease, pulmonary medicine, rare disease, oncology, or other specialty therapeutic areas preferred. Experience in pulmonary fibrosis, drug-device combination products, and/or inhaled therapeutics (INH) is highly desirable but not required. • Deep understanding of clinical development plans, clinical trial execution, drug development, regulatory requirements, with a focus on patient-centered drug development is essential. • Demonstrated ability to collaborate and lead with executive presence, positively influence performance excellence, and encourage innovation across all therapeutic areas and levels. • Experience working cross-functionally with internal stakeholders including clinical development teams, CMC, finance, medical affairs, portfolio management, and communications/corporate affairs. • PMP or similar project management certification is desirable. • Strong organizational and time-management skills, with the ability to manage multiple complex programs simultaneously, proactively identify and mitigate risks, and drive execution with urgency to achieve critical development and business objectives is essential. • Proficiency in project management tools (e.g., Microsoft Timeline, Smartsheet) and collaboration platforms. • Strong oral and written communication skills are essential, including the ability to influence and drive performance at all levels of the organization. • Self-motivated, independent, and able to work effectively in a small team and fast-paced environment. • Ability and willingness to travel ~15% for meetings as needed.