LeonaBio Benefits Overview

Leads LeonaBio’s Quality function through late-stage clinical development, regulatory approval, commercial launch, and lifecycle management. Responsibilities include building and scaling pharmaceutical QMS and QRM frameworks, ensuring global GxP compliance, leading inspections and audits, overseeing outsourced manufacturing and development partners, supporting drug substance and product quality, and developing the Quality organization. The role provides risk-based guidance to executive leadership and the Board while ensuring inspection readiness, reliable supply, and sustainable commercial operations.

Provides strategic and hands-on biostatistical leadership across clinical development programs, including trial design, statistical analysis plans, clinical data interpretation, regulatory submissions, interim analyses, and health authority interactions. Oversees external biostatistics and statistical programming partners, contributes to CDISC standards and processes, and advises cross-functional teams in a lean biotechnology environment.

Lead technical and strategic analytical development for small molecule drug substance and drug product programs. Oversee method development, validation, transfer, specifications, vendor management (CROs/CDMOs), regulatory authorship for global submissions, lifecycle/change control, data integrity and quality investigations, and cross-functional alignment to support development milestones and commercial readiness.