Parabilis Medicines

Manager

• Implementing and maintaining the company’s quality management system (QMS) to ensure compliance with regulatory requirements (e.g. FDA, EMA, ICH, etc.) and internal standards
• Manage the lifecycle of GxP documents to ensure compliance with regulations and internal procedures
• Manage workflows related to CAPAs (Corrective and Preventive Actions), Change Controls and Deviations and Investigations
• Support all inspection readiness initiatives including but not limited to self-inspections and regulatory inspections
• Support the tracking and reporting of quality KPIs (e.g., deviation closure time, audit findings, etc.) and assist in the preparation of slides, meeting coordination and presentation of quality trends to senior leadership
• Support qualification and approval activities of external suppliers
• Manage training requirements, curricula and learner roles in the company Learning Management System (LMS)

Quality Systems Manager

Director

• Provide strategic leadership and oversight of data management activities across multiple clinical programs, ensuring high-quality, inspection-ready data deliverables.
• Lead and develop data management staff while fostering collaboration across internal teams and external partners, including CROs and vendors.
• Oversee the end-to-end data management lifecycle, including study start-up, database build, data review, and database lock.
• Drive vendor oversight, study execution, and cross-functional coordination to ensure timelines, budgets, and quality expectations are met.
• Establish and enhance data management standards, SOPs, and processes to ensure compliance with GCP, ICH, and regulatory requirements.
• Provide strategic input into resource planning, budgeting, and continuous improvement initiatives across the function.

Associate Director, Data Management

Data Scientist

• Build and lead a cross functional data centric matrix to accelerate drug development.
• Support regulatory submissions and guide the Real-World Data (RWD) / Real-World Evidence (RWE) function at Parabilis.
• Responsible for end-to-end strategy and execution of RWD/RWE and clinical data science to inform trial design.
• Contextualize clinical results, support biomarker and translational work, and optimize site and patient selection.
• Partner closely with Clinical Development, Clinical Operations, Biostatistics, Translational/Computational Biology, Regulatory, and the broader Data Science & Engineering team.

Quality Systems Manager

Associate Director, Data Management

Vice President, Development Data Science