Maria Lizza Bowen
AUTHOR

Maria Lizza Bowen

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Maria Lizza Bowen is a pharmaceutical executive, clinical development leader, author, and published researcher with more than 30 years of experience spanning laboratory research, clinical operations, clinical science, clinical development, and quality.

She currently serves as head of protocol excellence in global clinical science, where she built and leads a global function focused on improving how clinical trial protocols are developed, governed, and used. Her work includes protocol standards and governance, structured and modular authoring, quality, training, and the thoughtful application of technology and AI to clinical development.

Throughout her career, Maria has worked at the intersection of science, process, and execution. Her experience includes direct responsibility for FDA inspections and inspection readiness as well as published clinical research in Blood. She also speaks at industry conferences on protocol design, patient burden, clinical development, and the evolving role of AI in protocol development.

The ideas behind Burden by Design grew from both professional experience and personal loss. Having spent decades working inside clinical development, Maria has seen firsthand how deeply committed people across functions make thoughtful decisions in service of the science, yet they may not always be able to see how those decisions accumulate for sites, patients, and caregivers. Navigating cancer care with both of her parents brought that reality into sharper focus and changed how she viewed the documents and decisions she had spent years helping create. What may appear as a single requirement within a protocol can become appointments, procedures, travel, waiting, caregiving, uncertainty, and time once it reaches the people living with it.

That perspective ultimately shaped a central theme of her work: Clinical trial burden is rarely the result of one poor decision. More often, it emerges from reasonable choices made across functions, systems, and stages of development without a clear view of their combined impact.

Maria is also the author of Reflect, a No. 1 Amazon bestseller and Hot New Release. She writes regularly about protocol design, patient burden, pharmaceutical innovation, AI adoption, leadership, organizational change, and the realities of clinical development through her blog and LinkedIn newsletter, Reality Bytes
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Best Sellers

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  • Reflect cover art
    Preview

    • Reflect

    • A Perspective on Understanding Your Reality and Becoming Unstuck
    • By: Maria Lizza Bowen
    • Narrated by: Maria Lizza Bowen
    • Length: 5 hrs and 16 mins
    • Release date: 01-08-23
    • Language: English
    • Not rated yet

    £11.60 or free with trial. Auto-renews at £5.99/month after trial. See eligibility.

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