Data Science


Current position
PhD, Advisor at Pallantius Inc
Business Strategy
Clinical Development



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
PhD, Biostatistics

Selected Publications

  • Isakov, L., Jin, B., and Jacobs, I. A. (2016). "Statistical Primer on Biosimilar Clinical Development." American Journal of Therapeutics 0(1). DOI: 10.1097/MJT.0000000000000391
  • Musselli, C., Isakov, L., and Wentworth, K. (2011). “Chapter 11. Emerging clinical trial design concepts for therapeutic cancer vaccines.” Cancer Vaccines: From Research to Clinical Practice. ISBN 9781841848297
  • Wood, C., et al. (2008). “An adjuvant autologous therapeutic vaccine (HSPPC-96; vitespen) versus observation alone for patients at high risk of recurrence after nephrectomy for renal cell carcinoma: a multicentre, open-label, randomised phase III trial.” The Lancet 372(9633). DOI: 10.1016/S0140-6736(08)60697-2
  • Jonasch, E. et al. (2008). “Vaccination of metastatic renal cell carcinoma patients with autologous tumour-derived vitespen vaccine: clinical findings.” British Journal of Cancer 98(8). DOI: 10.1038/sj.bjc.6604266

Request free information about Harbour.Space
1 minute to complete and fast response time

Thank you!
We call soon
Keep an eye out for an activation email in your inbox. Once you’ve followed the link in our email.
Log in

Forgot your password?

New To Harbour.Space?
I Already Have An Account
Create an account to get the access to the application process and more.

Password recovery
Enter your email and we’ll get back to you right away.
Thank you.
You're almost there.
Keep an eye out for an activation email in your inbox. Once you’ve followed the link in our email, you're all set.
Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt.