Building successful, sustainable operations
Successful development programs depend as much on people and processes as on scientific insight.
Cross-functional Program Leadership
Across my roles as Chief Science Officer, regulatory and quality leader, and board director, I’ve built organizations from the ground up, managed international teams, and overseen everything from GCP-compliant trial infrastructure to GMP manufacturing and nonclinical operations.
For Cannevert Therapeutics, a pharmacology-focused startup focused on developing novel analgesic compounds, I developed the company’s organizational structure and significantly expanded the scope of its preclinical operations. This included recruiting and training staff, designing SOPs and quality systems, managing the chemistry laboratory, and working with federal regulators to secure necessary licenses. As the organization grew, I became Director of Quality Assurance and Regulatory Affairs and guided the company through regulatory changes and evolving documentation requirements to achieve the milestone of launching a proof-of-concept human study. Later at Entheon Biomedical, I translated these organizational principles to an end-to-end clinical development program, directed cross-functional teams, and implemented new processes including a fully GCP-compliant trial master file to ensure audit-ready regulatory compliance.
