Aneesah Fladger
Director, Lead Operational Excellence, Medical Affairs Launch Excellence & Operations @Novartis
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WORK HISTORY
Director, Lead Operational Excellence, Medical Affairs Launch Excellence & Operations @Novartis
Operating at senior leadership scope with responsibility for Medical Affairs Operations, organizational transformation, and cross-functional execution across US functions.• Lead Medical Affairs Operations and operational excellence initiatives, supporting Medical Strategy Teams through standardized ways of working, governance, and execution models• Serve as line manager for Associate Director level Program Managers, providing coaching, prioritization, and performance management across complex portfolios• Lead large-scale organizational transformation initiatives, including process mapping, process engineering, and operating model redesign to improve execution and scalability• Drive implementation of LLM-enabled solutions and digital capabilities to modernize workflows, enhance decision-making, and improve operational efficiency• Establish standards, tools, and governance frameworks to enable consistent execution of medical strategy across functions to drive flawless execution and launch excellence• Partner closely with Commercial and cross-functional stakeholders to align product strategy execution, clarify handoffs, and improve end-to-end ways of working• Lead enterprise transformation initiatives focused on cost savings, efficiency gains, and reinvestment opportunities while maintaining quality and compliance
EDUCATION
Berkeley College-New York
Bachelor of Arts (BA), International Business
Penn State University
MBA, MPS
Harvard Medical School
Clinical Development Strategies – Beyond Clinical Trials Certificate
ABOUT ANEESAH FLADGER
Senior clinical operations and medical affairs operations leader with deep expertise in global trial execution, CRO, external partner and vendor governance, and operating model transformation complex therapeutic portfolios. I partner closely with C-suite leaders to shape strategy then translate that vision into execution plans that drive organizational alignment and operational excellence.I specialize in bringing structure and clarity to large-scale, global environments, particularly where organizations are managing fully outsourced trials, rapid portfolio growth, and cross-regional complexity. My focus is on building governance frameworks, operational processes, and leadership alignment that improve execution, inspection readiness, and decision-making at scale.Over more than two decades, I have led global portfolios spanning oncology (solid tumors, breast, hematology, lung, GU/GI), CAR-T, RLT, immunology, neuroscience, and CRM, across Phases I–IV. My experience includes oversight of fully outsourced global studies with individual trial budgets ranging approximately $200M–$500M, partnering with major CROs and complex vendor ecosystems including laboratories, imaging, and specialty providers.I bring hands-on leadership in global clinical operations and medical affairs operations, CRO oversight, ICH-GCP compliance, SOP development, audit and inspection readiness, process optimization and change management.I have led global teams of up to ~50 direct reports and influenced matrixed organizations exceeding 500 contributors, building empowered, accountable teams aligned to patient-centered outcomes. I have driven strategic collaborations and external partnerships supporting evidence generation and clinical development objectives. I establish standard operating models for vetting, initiating, and evaluating collaborations, ensuring alignment with scientific strategy, business priorities, and execution readiness, defining clear evaluation criteria, metrics, and KPIs, and to apply best practices across partnerships.A defining strength of my leadership is influencing stakeholders without formal authority and collaborating with executive leaders to translate strategy into execution.I am currently focused on leadership opportunities within Clinical Operations, CRO, Strategic Collaborations & External Partner Excellence, and Medical Affairs Operations, leading Program Managers, where disciplined execution, thoughtful governance, and strong people leadership are essential to advancing medicines for patients with unmet needs.
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