Anastasia Lesogor
Wenslingen,CH
Summary
Pharma Executive, specializing in Global Drug Development with >20 years of expertise in the field, including 17+ years at Novartis Pharma in Basel, Switzerland Proven track record of success, from initial submission & approval in various geographies (FDA, EMA, PMDA, CFDA and other) to comprehensive life cycle management (e.g. Tecturna, Galvus, Leqvio, Ferinject, Sandostatin) Extensive experience in a variety of therapeutic areas, including cardiorenal- metabolism, endocrinology, and oncology, with a focus on conditions such as atherosclerosis, heart failure, hypertension, obesity, diabetes, acromegaly, and neuroendocrine tumors. >30 publications, including peer-review journals and presentations at major scientific conferences.
Overview
24
24
years of professional experience
Work History
Senior Global Program Clinical Head
Novartis Pharma
Basel
06.2015 - Current
- Served as VP ad interim Global Program Head accountable for all aspects of development of a global program
- Spearheaded multiple clinical programs globally, spanning various indications and assets as a Senior Global Clinical Leader
- Influenced CM disease area strategy and held ownership of risk-benefit assessments
- Directed Global Clinical Teams, ensuring the strategic design, implementation, and execution of clinical development for two key assets
- Drove clinical programs to meet critical decision milestones, adhere to regulatory requirements, and achieve market access
- Provided line management for MDs/PhDs, including forecasting and allocating resources for clinical programs
- Engaged with Senior Management Boards to align internal strategy and vision effectively.
Global Clinical Program Head/ Global Program Medical Director/Executive Director
Novartis Pharma AG
Basel
04.2013 - 06.2015
- Global leader of the clinical development team, responsible for the aliskiren heart failure clinical program (2 Ph
- III registration studies), octreotide life cycle management development program
- Accountable as leader of the Global Clinical Team for design, implementation, execution, and submission/approval of a clinical development plan to support decision milestones, regulatory requirements, and budget targets
- Responsible for continuous evaluation of drug safety profile, including preparation of safety up-dates (PSUR, DSUR), IND/NDA submission and EU regulatory safety procedures (Article 20, Article 31) with support from Drug Safety & Epidemiology
- People line management and leading international teams.
Program Section Leader/Clinical Indication Leader/Senior Director
Novartis Pharma AG
Basel
05.2011 - 03.2013
- Leadership role in clinical development of aliskiren
- Functional management of 2 clinical teams (PhDs, MDs)
- Clinical leadership of outcome trials in heart failure area.
Principle/Senior Medical Scientific Expert/ Medical Scientific Expert/Clinical Research Physician
Novartis Pharma AG
Basel
01.2007 - 04.2011
- Lead in the preparation of registration dossier and medical support of registration/approval process
- Key responsible for IB updates, safety updates, IND/NDA submissions and responses to Health Authorities requests
- Interactions with key external and internal stakeholders (regulatory authorities, key opinion leaders, advisory boards, patient advocacy groups)
- Responsible for providing medical/scientific input and expertise to individual clinical trials and overall development program of a CVM disease area
- Leading the data analysis/publication project, close interaction with statisticians
- Medical input to planning, execution and reporting of clinical trials
- Development of trial related documents
- Medical input to Global Clinical Development Plans (eCDP, CDP)
- Preparation of key regulatory documents and meetings
- Ongoing review of clinical trial data, final analysis and interpretation
- Medical input to safety annual reports and safety updates.
Medical Advisor
Vifor (International) AG/Galenica Group
St. Gallen
08.2004 - 12.2006
- Clinical Leader of international trials
- Protocol writing for Phase II-IV trials
- Preparation and review of trial publications, abstracts, posters
- Preparation of trial budget
- Staff training, medical support of marketing and regulatory departments
- Input for IB and IMPD
- Contacts with the clinical/scientific community and with KOLs.
Clinical Trial Coordinator/ Clinical Research Manager
Quintiles GmbH
Vienna, Austria/Quintiles GmbH, Frankfurt/Main, Germany
04.2000 - 07.2004
- Supervision and coordination of international trials
- Co-monitoring and providing support for audit preparations
- Generate clinical study reports
- Liaison with IEC/IRB in Germany and Switzerland
- Feasibility assessment.
Education
MD -
St. Petersburg State Medical University
Medical Certified (Internal Medicine) -
Medical Genetics -
HMX Pro Genetics, Harvard Medical School
German language diploma -
Ludwig-Maximilians-Universität München
Statistics in clinical trials -
FORUM Institute for Management, Heidelberg
Personal Information
Nationality: Swiss
Languages
- German
- English
- Russian
Timeline
Senior Global Program Clinical Head
Novartis Pharma
06.2015 - Current
Global Clinical Program Head/ Global Program Medical Director/Executive Director
Novartis Pharma AG
04.2013 - 06.2015
Program Section Leader/Clinical Indication Leader/Senior Director
Novartis Pharma AG
05.2011 - 03.2013
Principle/Senior Medical Scientific Expert/ Medical Scientific Expert/Clinical Research Physician
Novartis Pharma AG
01.2007 - 04.2011
Medical Advisor
Vifor (International) AG/Galenica Group
08.2004 - 12.2006
Clinical Trial Coordinator/ Clinical Research Manager
Quintiles GmbH
04.2000 - 07.2004
MD -
St. Petersburg State Medical University
Medical Certified (Internal Medicine) -
Medical Genetics -
HMX Pro Genetics, Harvard Medical School
German language diploma -
Ludwig-Maximilians-Universität München
Statistics in clinical trials -
FORUM Institute for Management, Heidelberg
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