- Current position
- PhD, Advisor at Pallantius Inc
Leah Isakov is a senior leader in the pharmaceutical industry with a unique combination of leadership and technical skills. She has worked in clinical trials for more than two decades and is known for delivering results. Leah has led NDA (New Drug Applications), PMA (Pre-Marketing Approvals) and BLA (Biologics License Applications) and have deep experience interacting with all the major regulatory bodies (FDA, EMEA, PMDA, Russian Ministry of Health, and Health Canada). She also has direct experience successfully managing cross-cultural international teams (USA, China, Japan and Canada). The recent therapeutic areas include Oncology, Infectious Diseases, Cardiovascular, Asthma, Renal Failure and HIV for Phase II-IV clinical trials in drugs and biologics.
As a leader, Dr. Isakov strives to be at the forefront of management practice. She incorporates data-driven decision making and quantitative risk management, and focus on building internal capabilities along with external collaborations. Leah believes that successful management comes from understanding the full organisational stack; that is, not only high-level strategy but also the technical aspects that enable success.
Global Head of BioStatistics, Data Management, Programming and Medical Writing Seqirus Oct 2016 – Present
Senior Director, Clinical Statistics / Biosimilars Statistical Lead
Feb 2014 – Oct 2016
Senior Director of Biostatistics, Statistical Programming and Data Management
2004 – 2014
Associate Director, Biostatistics
AAI Development (formerly MTRA) 1998 – 2004
MIT Sloan School of Management, Cambridge, MA
Boston University, Boston, MA