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Lindsay McNair, MD, MPH, MSB
Chief Medical Officer, WCG (Former)
Biography
Dr. Lindsay is the former Chief Medical Officer for WCG. She oversaw the physician team within the WCG IRBs, and provided consultation to institutions and pharma/biotech companies on a wide range of issues related to protocol design, regulatory compliance, human subject protection, and ethical policy development (pre-approval access, subject compensation).
Prior to joining WCG, Dr. McNair was a consultant to multiple biopharma companies, providing medical guidance on clinical development strategies and study designs for new drug studies, and medical oversight of all phases of clinical trials. Before becoming a consultant, Dr. McNair was the medical lead for the telaprevir development program at Vertex Pharmaceuticals, with oversight of the phase 1-3 studies.
Dr. McNair is adjunct faculty at Boston University and teaches graduate courses on the scientific design of clinical research studies.
Dr. McNair graduated from the University of Connecticut School of Medicine and trained in general surgery at Boston University Medical Center. She completed her Master’s in Public Health at Boston University concentrating in Biostatistics/Epidemiology, and her Master’s of Science in Bioethics at Union Graduate College concentrating in research ethics.
Dr. McNair is an associate editor for the Journal of Empirical Research on Human Research Ethics, and serves on multiple committees including the NYU Compassionate Use Pre-Approval Access (CUPA) Working Group, the Human Subjects Review Board of the US Environmental Protection Agency (EPA HSRB), and the Advancing Effective Research Ethics Oversight (AEREO) consortium.
Latest insights by Lindsay
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Reviewing the FDA’s Proposed Informed Consent Rule Changes
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Understanding the FDA’s new proposed regulations on human subject research and their impact on your clinical trial plans
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Do we need to submit screenshots of eCOA/ePRO diaries?
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Drafting a Research Plan for IRB Review and Research Conduct: Information That Must Be Included in a Clinical Trial Protocol
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Complex Clinical Trial Protocol Designs: The Effect on Research Sites and the Role Central IRBs Play in Ensuring Quality
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Can a protocol get IRB approval during the 30-day IND waiting period?
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Does my customer survey project require IRB review?
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Increasing Clinical Trial Participation Through Eligibility Expansion and Inclusivity Considerations
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Making Clinical Research Inclusive: Strategies to Include the LGBTQIA+ Community in Research Trials
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