Avalyn Pharma

Compliance

• Support development and execution of global regulatory strategy
• Oversee global regulatory submissions and health authority interactions
• Lead regulatory activities for assigned development programs
• Collaborate with cross-functional teams to integrate regulatory considerations

Senior Manager – Regulatory Affairs

Director

• Part of clinical development team, as the statistical lead for one or more clinical programs spanning early through late phases (I-III)
• Provide strategic input into clinical development plans, study strategy, study design, endpoint evaluation and selection, estimate development, and analysis strategies.
• Provide innovation in clinical studies with regulatory knowledge to support efficient, risk taking during development
• In collaboration with the study team, oversee and critically review protocols, SAPs, randomization schemes, and interim analysis plans.
• Ensure alignment of statistical approaches with regulatory guidance and standard of care medical practices
• Provide oversight of vendor statistical activities, including deliverable review, issue resolution and budgetary allocation
• Lead statistical contributions to regulatory submissions (INDs, NDAs, BLAs, MAAs).
• Represent Biostatistics in interactions with FDA, EMA, and other global health authorities.
• Ensure statistical outputs are clear, defensible, and aligned with regulatory expectations.
• Establish clear expectations for scientific quality, timelines, and accountability of Data Management and Statistical Programming.
• Support hiring and resourcing strategies that scale with program needs.
• Build fit-for-purpose statistical standards, templates, and processes.
• In collaboration with the Clinical Development and Medical Affairs lead, ensure timely execution of clinical development plans.
• Ensure compliance with ICH, GCP, and internal SOPs.
• Drive consistency and quality across statistical deliverables while enabling flexibility where appropriate.
• Stay current with evolving regulatory guidance and statistical methodologies.
• Champion appropriate innovation, including adaptive designs, Bayesian approaches, and data-driven decision frameworks.

Senior Manager – Regulatory Affairs

Director, Biostatistics