Christina M. Shay

About Christina M. Shay

I’m a real‑world evidence leader and epidemiologist who builds the strategies, structures, and partnerships that turn data into influence — and ultimately, into better decisions for patients. Over my career, I’ve led integrated evidence planning across multiple therapeutic areas, designed innovative RWE studies that shape clinical and regulatory strategy, and partnered globally to embed RWD into the DNA of product development.What I love most (and do best) is helping organizations elevate their evidence thinking: connecting clinical, medical, HEOR, market access, and regulatory stakeholders around a unified evidence narrative that drives clarity, speed, and smarter strategic choices. I thrive at the intersection of science, operations, and communication — translating complex epidemiology and RWE insights into simple, compelling messages that shape strategy at the highest levels.My experience spans global pharma, CRO, and nonprofit healthcare sectors, giving me a uniquely well‑rounded view of how to design, govern, and operationalize evidence programs that scale. I’ve led epidemiology and RWE efforts for one of the largest assets at a top pharmaceutical company, delivered RWE-based regulatory and market access packages, and developed integrated evidence plans that align teams, accelerate timelines, and reduce operational burden.I lead RWE strategy, strengthen integrated evidence planning, modernize how evidence is generated, or simply bring order, influence, and excitement to a complex evidence ecosystem — that’s where I’m at my best.Specialties:Real‑World Evidence Strategy • Integrated Evidence Planning • Epidemiology • RWD Integration in Clinical Development • RWE for Regulatory & Market Access • Cross‑Functional Leadership • Evidence Operations • Data Landscaping • RWE Study Design • Stakeholder Engagement & Communication • Team Leadership

Experience

1. Director, Global Epidemiology and Rwe

   Boehringer Ingelheim

   Nov 2021 — Present · Ridgefield, CT, US

   Independently manages complex RWE projects, streamlining processes and delivering actionable insights for successful integrated evidence generation.• Spearheads the development and implementation of a global epidemiology/RWE strategy for the company’s largest asset, ensuring cross-functional alignment • Leads design, execution, and reporting of epidemiology/RWE studies, as an integrated RWE contributions in regulatory submissions and market access strategies.• Provides strategic and methodological leadership, integrating RWD into clinical development and regulatory decision-making processes.• Advocates for the value and utility of RWE across the product lifecycle, through driving evidence- based decision making. • Cultivates relationships with external stakeholders, including data partners, and external experts to advance RWE approaches.• Simplifies complex epidemiological concepts and findings for non-technical stakeholders, enhancing understanding and facilitating informed decision-making.

Education

• Kent State University

  Master of Arts, Exercise Physiology

  2001 — 2003

• McGill University

  Graduate Course, Pharmacoepidemiology III

• University of Pittsburgh

  PhD, Epidemiology

  2004 — 2009

• Northwestern University - The Feinberg School of Medicine

  Post Doctoral Fellowship (NIH T32), Cardiovascular Disease Epidemiology

• Harvard Medical School Corporate Learning

  AccelerateEX Program

• Harvard Medical School Corporate Learning

  Accelerate Teams

Skills

• Medical Education
• Leadership
• Higher Education
• Public Speaking
• Clinical Research
• Research Design
• Science
• Research
• Medical Research
• Teaching
• Health Education
• Epidemiology
• Public Health
• Genetics
• Medicine
• Sas
• Statistics
• Clinical Study Design
• Spss
• Literature Reviews
• Biostatistics
• Lifesciences