Project Manager Pharmaceutical Industry

3/2016 – 9/2016

Organizing and Coordinating Drug Supply for patients in several countries

Projektmanagement

7/2015 – 3/2016

Responsible for all operational aspects of organizing and controlling global IITs (negotiating with CPOs, legal, finance, DSM, investigators), Grants (negotiating with CPOs, legal, finance, compliance department, payments); budget control of the team budget, organizing finance approvals, payments as well as supporting the team for any other operational aspects of activities.

Projektmanagement

3/2015 – 6/2015

Responsible for vendor selection (CROs) for clinical studies and starting a clinical trial in USA (organizing and leading the kick-off meeting) until the new Head of Clinical Operations could join the company.

Projektmanagement, Projektmanagement - Angebotsmanagement, Projektmanagement - Benchmarking, Projektmanagement - Konzeption / Vorgehensmodell

6/2014 – 12/2014

Responsible for data review and cleaning of a global registration study and supporting the team in all aspects of preparation of the study report

Medical Writing

4/2014 – 5/2014

Responsible for supporting the international team in all aspects of starting a new global trial, mainly writing the clinical study protocol and defining the CRF and PDs.

Medical Writing

6/2013 – 3/2014

Responsible for starting 2 new global studies in close relationship with the study manager and the medical person, mainly writing the clinical study protocol and defining CRFs and PDs with statistician and data managers

Medical Writing

6/2013 – 3/2014

Responsible for starting 2 new global studies in close relationship with the study manager and the medical person, mainly writing the clinical study protocol and defining CRFs and PDs with statistician and data managers

Medical Writing

1/2013 – 6/2013

Beratung bei der Durchführung von klinischen Projekten, Medical Management

Forschung & Entwicklung

12/2012 – 12/2013

Beratung bei der Durchführung klinischer Studien

Forschung & Entwicklung, Klinische Forschung

3/2009 – 2/2011

Unterstützung und Beratung des CEOs und Project Managers in allen Belangen der Projektentwicklung ( vom Labor zur Klinik)

11/2007 – 3/2011

Project Management um das erste Project vom Labor zur Klinik zu führen. Vom Labor zur Klinik ( erster Patient in der Studie) innerhalb 2 1/2 Jahren. Leitung eines Teams von 7 Experten plus CMO and CROs

4/1998 – 6/2008

Mitbegründer der CRO Hesperion (später Averion, jetzt Aptiv Solutions), Gründer der Hesperion Deutschland, die dann an Actelion Deutschland verkauft wurde. Haupttätigkeiten: Managing Director,Project Management und Business Development. Mitverantwortlich für die Durchführung folgender Studien:
Phase I/II Study in Glioblastoma: Germany, Russia, India
Phase III Study in Renal Cell Carcinoma: USA, Europe, Russia
Phase I Studies for NCEs in Oncology : Germany
Phase II Studies for NCEs in Prostate Cancer: Germany, France
Phase I Study in Severe Brain Injury ( Biotech Product): Germany
Phase III Study for NCE in Chronic Heart Failure: USA, Europe
Phase III Study for NCE in Pulmonary Arterial Hypertension (PAH): Mexico, Europe
Phase II studies for NCEs in Friedreich's Ataxia and in Leber's Hereditary Optic Neuropathy: Canada, Europe

2/1995 – 1/1998

Business Development & Strategic Marketing
Pharmaceutical Division
International Medical Manager for Neupogen® Senior Scientist
Responsibilities:
• Leading the Medical Team for NeupogenÒ reporting to the
Amgen-Roche Joint Development Team;
• Management of clinical trials phase III and phase IV;
• coordination of international study centers and groups;
• clinical trials reporting; auditing;
• Scientific Lectures at National Meetings in Europe, Middleand
Far East

5/1986 – 1/1995

Development (phase I - phase III) and Registration of GMCSF
(Leucomax®) in cooperation with Schering-Plough Ltd.
• International lecturing at Conferences and Launch
Meetings;
• Life cycle management after registration.
• Clinical Development of anti-viral monoclonal antibodies;
lipid A analogue as cytokine stimulator; novel
antirheumatic, oncological, dermatological and
antiinfectious agents from phase I - phase IV.

10/1983 – 4/1986

Forschung und Anwendung der autologen Knochenmarkstransplantation bei Kindern mit Non-Hodgkin -Lymphomen und bei Erwachsenen mit Leukämien