Medical Advisor clinical research, outcomes research, pricing and reimbursement

MD, PhD, pharmaceutical professional with more than 20 years of experience in planning, conducting/managing/supervising clinical trials phase I-IV, non-interventional studies, registries and HEOR/P&R-projects, on strategic and operational level

• Klinische Forschung
• Medizin13 J.
• Projektleitung / Teamleitung

Brief Summary

MD, PhD, pharmaceutical professional with more than 20 years of experience in planning, conducting/managing/supervising clinical trials phase I-IV, non-interventional studies, registries and HEOR/P&R-projects (incl. burden/cost of illness, value dossiers, modeling) . Comprehensive experience in medical, marketing and market assess on strategic and operational level (pharmaceutical industry and academia). Deep knowledge of health care systems. Founded in 2008, since 2011 full engagement.
Additional Information

As executive head of the Clinical Study Center (CSC) at the Ludwig-Maximilians University of Munich/Germany I have successfully developed the CSC to function as an internal CRO of the university hospital. Therefore I am familiar with internal structures and procedures especially for legal requirements and contracting as well as intelligence property.
During my engagement in the pharmaceutical industry as senior medical advisor/ manager / project leader in clinical research / outcomes research I was involved market access activities of new drugs in different therapeutic areas (pain, arthritis, CNS, hepatitis, diabetes, dermatology, orphan diseases, oncology, Alzheimer’s disease). This comprised the strategic planning of launch activities and reimbursement aspects in ICH countries (EU, US and Japan). For more information including a publication list please visit the homepage.
My individual characteristics: Working strictly in line with legal, ethic and social requirements, integrity commitment with companies and clients, identification with the projects, highly motivated and success driven, creative and well structured kind of thinking, ability to bring projects forward and to make decisions, excellent interpersonal skills especially to build up and lead (cross-functional) teams resulting in a positive and successful manner as a team player

My Offering to You

I am offering interim solutions as a medical advisor/director with focus on strategic and operational activities regarding study management outcomes research and P&R. My services include support of core teams to cover peaks and/or “bridging the gaps” until the ideal person has been found to cover the position, permanently.

In Detail

Development of study protocols (phase I-IV, NIS, registries, cost/burden of illness, QoL studies including alternative study designs regarding P&R), medical supervision of additional study documents (e. g. ICF, CRF), medical input for modeling, communication with internal and external stakeholders (especially CROs including selection process, budget discussion and contracting)

Potential Clients

The described services are addressed to big pharmaceutical industry and small biotech companies as well as to academia having a focus on clinical research.

Procedure

If a client is interested to work together with me, it is essential to discuss client’s requirements in detail. If needed, we recommend additional service providers as we are strongly connected with a large number of highly specific providers, too.

MD, PhD