Rob Kalesnik Orszulak
About Rob Kalesnik Orszulak
Rob Kalesnik Orszulak is the Senior Director of Global Regulatory Strategy at Bristol Myers Squibb, with extensive experience in immunotherapy, immunology, cardiovascular, and virology.
Title and Current Role
Rob Kalesnik Orszulak currently holds the position of Senior Director, Global Regulatory Strategy at Bristol Myers Squibb. In this role, he is responsible for leading regulatory strategy on a global scale, primarily focused on the development and registration of advanced therapies. He plays a key role in engaging with regulatory bodies to gain approval and ensure compliance with international regulations.
Career at Bristol Myers Squibb
Rob Kalesnik Orszulak has been with Bristol Myers Squibb in various roles since 2019. Prior to his current role, he served as Director, Global Regulatory Strategy from 2021 to 2022, and before that, as Associate Director, Global Regulatory Strategy from 2019 to 2020. Throughout these positions, his work has involved leading efforts in immunology, cardiovascular, and virology drug development. His experience spans various product types, including biologics, cell and gene therapies, and small molecules.
Experience in Academia and Internships
Rob Kalesnik Orszulak was an Adjunct Professor at Rutgers University, specifically at the Ernest Mario School of Pharmacy, from 2015 to 2017. During his tenure, he contributed to pharmacy education in Piscataway, New Jersey. Additionally, he gained early experience through internships at the FDA in Silver Spring, Maryland, in 2015, and at Ziopharm Oncology in Boston, Massachusetts, in 2014.
Educational Background
Rob Kalesnik Orszulak achieved his Doctor of Pharmacy (Pharm.D.) degree from the University of Rhode Island. His educational background laid the foundation for his expertise in the fields of immunology, cardiovascular, and virology. This robust academic foundation has been instrumental in his career focus on regulatory strategy and drug development.
Expertise in Innovative Therapies
Rob Kalesnik Orszulak has focused his efforts on the development and regulatory strategy for immunotherapy in hematology and oncology over the last decade. He is also keen on advancing the use of artificial intelligence (AI) and real-world data (RWD) in drug development and registration. This focus includes working closely with regulatory bodies to advance innovative therapies that aim to significantly improve patient lives.