Experience

Lakewood-Amedex Inc.
• United States
• Biotechnology Research
• 1 - 100 Employee
• SVP Clinical Development

  • Nov 2022 - Present


Exact Sciences

• United States
• Biotechnology Research
• 700 & Above Employee

• VP, Head Clinical Development MCED

  • Jul 2021 - Feb 2022

  Led Clinical Development efforts for the company's Multi Cancer Early Detection (MCED) liquid biopsy assay and designing/advancing a clinical evidence generation plan to support FDA approval. Led Clinical Development efforts for the company's Multi Cancer Early Detection (MCED) liquid biopsy assay and designing/advancing a clinical evidence generation plan to support FDA approval.



Freelance

• Egypt
• Human Resources
• 1 - 100 Employee

• Retired

  • Jun 2020 - Jun 2021

  Project based consulting engagements in Global clinical Development and Medical Affairs Project based consulting engagements in Global clinical Development and Medical Affairs


Bayer US LLC
• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee
• VP, Senior Medical Advisor

  • Jan 2020 - May 2020


Bayer U.S. LLC

• United States
• Mechanical Or Industrial Engineering
• 1 - 100 Employee

• VP, Head Global Medical and Clinical Affairs Radiology

  • Mar 2013 - Dec 2019

  Responsible for all medical aspects of Bayer's Radiology Business, including Global Clinical Development and Global Medical Affairs for pharmaceuticals, medical devices & artificial intelligence projects. Formed and led an integrated Global Medical & Clinical Affairs group of 35+ in multiple locations (US, Singapore, and Germany) by merging the former Global Development and the former Global Medical Affairs group, as well as integrating Medical Devices with the pharmaceutical business. Focused on strategic planning and brand positioning. • Achieved successful sNDAs for 3 additional Gadovist phase 3 indication programs (CV and Oncology) • Established an internal Imaging core lab as image service group for all of Bayer with focus on oncology and cardiovascular developments ◦ Spearheaded transformation from a service organization to a profit and excellence center for Bayer Pharma ◦ Ensured inspection readiness for the Imaging core lab for successful FDA Inspection of Core Lab in 2010, 2014, 2016, and 2019 • Led Task Force on a safety-related topic; successfully guided through EU Referral, FDA hearings, and FDA advisory board • Initiated an effective thought leader management and strategic engagement process with clear accountabilities, process transparency, and a clear mission how to best generate necessary insights from thought leaders and offer scientific value to them • Shaped overall brand strategy and performance by Global and Regional Brand Planning and Brand support • Chair of Safety Committee and member of PQSC • Successfully led/guided multi-company cooperation projects as member of joint project teams and steering committees



Bayer HealthCare Pharmaceuticals

• United States
• Pharmaceuticals
• 1 - 100 Employee

• VP, Head Global Clinical Development, Diagnostic Imaging

  • Aug 2006 - Feb 2013

  Led Global Clinical Development function for Diagnostic Imaging. Supervised up to 35 on different continents. Drove quality and innovation efforts for clinical development within industry segment. Functioned as part of the Global Business Unit Management Team contributing to strategic planning and served as Member of the Bayer Pharma Development Leadership Team, as well as on the Global Safety Committee, Global Labeling Committee, and Protocol Review Committee. • Built Global Clinical Development group for Molecular Imaging/targeted PET tracers ◦ Successful development of PET tracer for the diagnosis of dementia/Alzheimer's disease; "ready for submission documents" were handed over to Piramal Imaging ◦ Several exploratory INDs for molecular Oncology Imaging tracers • Implemented clinical exit-strategy for the molecular PET tracer business to divest that portfolio part • Achieved efficiency gains of six months in overall development time and 35M+ Euros as team lead for a project, analyzing, and optimizing critical processes and organizational structures for Global Development, Global Clinical Operations, and Global Medical Affairs at Bayer HealthCare Pharma • Prioritized development activities expanding portfolio in U.S. (new indications) in the MR modality


Berlex
• Sweden
• Public Safety
• 1 - 100 Employee
• Executive Director, Medical Affairs U.S. Diagnostic Imaging

  • Jan 2005 - Jul 2006

Berlex Biosciences
• Pharmaceutical Manufacturing
• 1 - 100 Employee
• Director Medical Affairs

  • Jan 2004 - Dec 2004


Schering AG

• Germany
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Head clinical Development MR Contrast Media

  • 1997 - Mar 2002

• Scientist Clinical Development Ultrasound and MRI contrast Media

  • Dec 1991 - 1997



Benjamin Franklin Hospital, Free University Berlin

• Residency Internal Medicine (Dep. of Gastroenterology and Infectious Diseases)

  • 1984 - Nov 1991

  Full 7 year residency covering all sub specialties of Internal Medicine with focus on Gastroenterology and Infectious diseases (e.g.HIV) Full 7 year residency covering all sub specialties of Internal Medicine with focus on Gastroenterology and Infectious diseases (e.g.HIV)