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
Reviewing the FDA’s Proposed Informed Consent Rule Changes
Whitepapers
Drafting a Research Plan for IRB Review and Research Conduct: Information That Must Be Included in a Clinical Trial Protocol
Whitepapers
Can a protocol get IRB approval during the 30-day IND waiting period?
Blog Posts
Does my customer survey project require IRB review?
Blog Posts
Is IRB review required when linking to clinicaltrials.gov postings on patient advocacy websites and newsletters?
Blog Posts
Can participants be reconsented over the phone when an ICF is updated?
Blog Posts
Virtual Clinical Trials: Best Practices in Moving Toward a Patient-Centric Research Model
Whitepapers
Is IRB review required for survey results that may be published?
Blog Posts
Single-Patient Expanded Access: WIRB experience in 2018
Blog Posts