Our partner is a commercial-stage biopharmaceutical company focused on discovering, acquiring, developing, and commercializing therapeutic medicines for patients with debilitating diseases and significant unmet medical needs. Their immune-modulating assets are based on strong biologic rationale and validated mechanisms, targeting a range of underserved cardiovascular and autoimmune conditions, with the potential for differentiation in treatment.

This critical hire provided expertise in Good Clinical Practice, ensuring clinical trials were conducted in compliance with regulatory standards. They assessed and developed quality systems, performed audits, and advised on risk management strategies to maintain data integrity and patient safety. They reviewed clinical trial documentation, provided GCP training, and supported regulatory inspections, working closely with clinical teams to resolve quality-related issues and ensure compliance throughout the clinical development process.