Rob Kowalski
US Country President, (ad interim) Head of Regulatory Affairs, Novartis US Head of Global Drug Development
Rob Kowalski is the US Country President ad interim, Head of Regulatory Affairs for Novartis, and the US Head of Global Drug Development (GDD). In his role as Country President, Rob is responsible for Novartis corporate functions in the US, driving cross-divisional and cross-functional collaboration across the enterprise ensuring a One Novartis approach to shaping corporate reputation for Novartis in the US. He also serves as Head of the Novartis U.S. Country Leadership Team.
In his more than 25-year career, Rob and his teams have successfully developed and registered over 100 new chemical entities, new indications, and devices across a wide array of therapeutic areas in the small molecule, biologics, biosimilar, and cell and gene therapy spaces. Since joining Novartis in 2009, Rob has served in various leadership roles within the Novartis Development organization, and played an integral role in bringing many breakthrough innovations to market including, Gilenya®, KymriahTM, Entresto®, Adakvio®, and Kesimpta®, among others.
In addition to being an active member in multiple professional organizations, Rob is the past-Chair of PhRMA’s Regulatory Affairs Committee and Vice-Chairman of the Board of Directors for the R&D Council of New Jersey. Rob was a member of the FDA Rare Disease Advisory Panel and an industry representative for PDUFA 5, 6, and 7 FDA reauthorization negotiations. He is also a founding member of the Industry Pharmacists Organization Advisory Board and a past-member of the TOPRA Advisory Council.
Rob held past regulatory leadership roles at Pharmacia (now Pfizer) and Schering-Plough (now Merck). He has also previously served as the Global Head of Development Medical Affairs for Novartis. Rob attended the University of Wisconsin–Madison where he received both a Bachelor of Science in Pharmaceutical Sciences and a Doctorate in Pharmacy. Rob completed his post-doctoral training at Rutgers University/Sandoz Pharmaceuticals and has trained at the Executive Forum of the Harvard Business School.