Jeffrey Gelb, MD

Jeffrey Gelb, MD is a strategic, results-oriented physician with 20+ years global drug development and medical affairs experience in biotech, pharma and CRO settings. Jeff has broad industry expertise with emphasis on specialty medicines including immunology, rare diseases and biologics. Jeff leverages his expertise to provide drug development, medical affairs, and clinical research strategies and execution support to biotech companies and other pharmaceutical industry organizations to advance medicines through development, licensing and commercialization. He applies his strong innovation, cross-functional leadership, problem solving, team building, clinical, regulatory, and medical communication skills to solve complex drug development challenges.

Prior to his work as a consultant, Jeff worked at the biotech company NPS Pharmaceuticals (and then with Shire following the acquisition of NPS) as Vice President R&D Program Leadership for 2 years where he created, built and led the cross-functional development teams to define strategies and advance the pipeline in rare/orphan diseases. Jeff was a key member of the successful Natpara FDA advisory committee team, created development and lifecycle strategies across the portfolio, and pursued global filings.

Previously, Jeff had worked at Covance for 3 years as Global Vice President, Molecule Development Group, where he built and led a global drug development function to strategically design and manage outsourced drug development programs. He consulted and partnered with multiple biotech companies globally across therapeutic areas and phases, to advance medicines through development milestones, mostly transitions into phase I first in human studies, and through proof of concept and phase IIb/III.

Jeff worked for Bristol-Myers Squibb (BMS) for 9 years across the business. He was Vice President, Global Development Lead for Nulojix (belatacept) where he led the full development team for solid organ transplantation in immunology. Jeff successfully filed and defended the BLA in the US and the MAA in Europe which resulted in US, European and other approvals. He led the team for the FDA advisory committee that resulted in a 13-5 positive vote, and he created an innovative risk management plan and REMS which were integral to the US and European approvals. 

Earlier at BMS, Jeff focused on Orencia (abatacept) in rheumatoid arthritis as part of the team that secured European market authorization, addressed FDA issues about immunogenicity, and advanced the subcutaneous drug-device product toward approval. Jeff also led the Immunology Protocol Review Committee for all studies in phases I-IV across all indications in immunology. Also at BMS, Jeff led clinical research for ConvaTec in medical devices, and established a health economics and medical communications function. He was Medical Director, Cardiovascular in US Medical Affairs working on a portfolio of cardiovascular products at different lifecycle stages.

Jeff worked at Johnson & Johnson (J&J) for 5 years in the Ortho Biotech division focused on Procrit for anemia in surgical and critical care settings, and led the clinical operations and field medical liaison functions in those indications. Prior to J&J, Jeff was a Medical Director at Total Learning Concepts where he developed, wrote and edited programs to launch new medicines and educate about managed care.

Jeff earned his MD degree from the University of Pennsylvania and his Bachelor of Science (BS) degree in Biology and Classical Studies from Tufts University.

Jeff is based in Florida.

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