Drug Development Expert, QA, PV

I a physician with in depth knowledge of drug development of pharmaceuticals and biotech compounds as well as generics including a strong knowledge base of QA principles, Audits and pharmacovigilance

• Change Management
• Fusionen und Übernahmen
• Management (allg.)
• Markenbildung
• Medizinforschung
• Produktmanagement
• Projektmanagement
• Qualitätsmanagement (allg.)
• Unternehmensberatung

CAREER & EXPERIENCE


05/2010 06/2012 BalkanTrials Ltd., Sofia, Bulgaria, Macedonia, Serbia, Germany
Chief Medical Officer
Implementation of a QA system, hire and training of CRAs, Start of clinical trials from phase I to phase IV.
Implementing the representative offices in Macedonia and Serbia and initiation of the regulatory process in non-EU countries for clients
Experience: Oncology/Hematology, Cardiology, Pediatrics, Pulmonology, Psychiatry, Rheumatology, Dermatology, Immunology

Reporting to: Owner
People reporting to me: 38 from cross functional teams in different countries of the Balkans plus Austria, Germany, Sweden, Finnland and Norway




2003 - 2010 Founder and Managing Director, Associated Medical Ltd.,
Sofia and Stara Zagora, Bulgaria
Implementation of a QA system, Hire and training of CRAs, Start of clinical trials from phase I to phase IV
Experience: Allergy/Immunology, Cardiovascular/Metabolic, CNS, Dermatology, Endocrine/Metabolism, Hematology, Infectious Diseases, Pediatrics, Pschychiatry, Pulmonology
Clinical Trial Site Audits in Macedonia, Serbia, Bosnia-Herzegovina, Croatia, Romania, Austria, Switzerland, Germany, France, USA
Vendor Audits: Central Laboratories, Web-based data capture, CTMS,
Data Management, Statistics

Reporting to: Owner
People Reporting to me: 68 from cross functional project teams in Bulgaria, Romania, Macedonia, Serbia, Croatia, Bosnia-Herzegovina, Austria, Germany



2000 - 2005 Founder and Managing Director, Associated Medical Ltd., Ruda lska, Poland

Implementation of a QA system, Hire and training of CRAs, Start of clinical trials from phase I to phase IV.
Experience: Allergy/Immunology, Cardiovascular/Metabolic, CNS, Dermatology, Endocrine/Metabolism, Hematology, Infectious Diseases, Pediatrics, Pschychiatry, Pulmonology, Rheumatology

Clinical Trial Site Audits and Vendor audits in Ukraine, Russia, Bulgaria, Sweden, Finland, USA, Germany: Phase I units, EDC, Data Management, Drug Safety

Reporting to: Owner
People reporting to me: 34 from cross functional project teams in Poland




1998 - 2000 Senior Programe Director, Cooperative Clinical Drug Development GmbH, Berlin, Germany

Revision of the QA system, Principle Investigator for 17 BE trials, Initiation an Management of 42 BE trials in cooperation with Queen Joanna Hospital, Sofia, Bulgaria

Experience: Allergy/Immunology, Cardiovascular/Metabolic, CNS, Dermatology, Endocrine/Metabolism, Hematology, Infectious Diseases, Pediatrics, Psychiatry, Pulmonology, Veterinary
Vendor audits: Phase I units, EDC, e-diaries, Data Management

Reporting to: Owner and CEO
People reporting to me: 24 in Germany and Sofia, Bulgaria


1997 PAREXEL, Director Clinical Pharmacology Unit, Georgetown University Washington, DC, USA,
12 month intermediate management assignment

Establishment of a QA system, Execution of 23 Phase I trials as Principle Investigator.
Experience: Allergy/Immunology, Cardiovascular/Metabolic, CNS, Dermatology, Endocrine/Metabolism, Hematology, Infectious Diseases, Pulmonology
Vendor auditing, eDiaries, EDC

Visiting Professorship in Clinical Pharmacology, Georgetown University Washington, DC, USA
Lecture Series Introduction into Clinical Pharmacology: Anti-arrhythmic Drugs

Reporting to: Head of Phase I worldwide, Prof. Dr. med. Werner Hermann, Berlin, Germany

People reporting to me: 24 from BD, Phae I physicians, Nursing staff, Advertising staff

1996 Department of Clinical Pharmacology, Humboldt University, Berlin, Germany
WHO Collaborating Centre for Reproductive Toxicology
Pharmaco-genetic aspects of treatment of cardiovascular diseases

Reporting to: Chair aof Clincal Pharmacology, Prof. Dr. med. Ivar Roots
People reporting to me: 3 assistant physicians, 12 students


1992 1996 Head of Research and Development HELOPHARM, Berlin-Germany