anne rubin

Lead strategic planning and operational execution for a Phase 2/3 breast cancer program, implementing GCP standards, vendor selection, and CTMS optimization to drive enrollment and quality across sites.

Lead strategic planning and operational execution for a Phase 2/3 breast cancer clinical program, developing budgets, vendor selection, CTMS implementation, and GCP-aligned site management to optimize enrollment and quality.

Led program-level oversight for US medical affairs clinical programs in gastroenterology and rare disease, implementing risk-based monitoring and delivering multi-million dollar program budgets with operational and quality improvements.

Led project management for the Phase 3 COVID-19 vaccine trial, overseeing 99 sites and 30,000 participants in three months and implementing diversity-focused recruitment and FDA audit-ready quality controls.

Oversaw multiple Phase 1-4 clinical programs across cardiovascular, metabolic, and rare disease areas with a portfolio exceeding $50M, improving operational efficiency 20% through mentoring and process innovation.

Directed operational execution of a $300M global diabetes cardiovascular outcome study across 60 countries, managing CRO partnerships, technology integration, and regulatory inspection readiness.

Managed a Phase I breast cancer trial across the US and India that produced positive results and advanced the program to Phase 2, overseeing operational execution and cross-border site coordination.

Led a large multicenter 1,000-subject global HIV post-marketing study for Kaletra, overseeing monitoring activities and compliance with regulatory requirements.

Bachelor of General Studies in Psychology focusing on foundational psychological theory and research methods.