Pharma & MedTech Consulting

35 years of Pharma/MedTech experience/6 companies, last role as Med. Dir. CE & EE. Medical Affairs & Drug Safety. Clinical Research PH I-IV. Focus on Oncology, Urology, Cardiology, Radiology, Nuclear Medicine, Neurology, Immunotherapy, Hematology .

• Arzneimittelsicherheit
• Humanmedizin
• Klinische Forschung
• Medizinische Technologie
• Medizinische Wissenschaften
• Nuklearmedizin
• Onkologie
• Personalführung
• Pharma / Kosmetik
• Radiologie

Skills & Experience:
Acute Lymphatic Leukemia, Mantle Cell Lymphoma, Multiple Myeloma, Diffuse Large B-Cell Lymphoma, flow cytometry, liquid biopsy, solid tumors, molecular imaging, radiology, nuclear medicine, bladder cancer, prostate cancer, renal cancer, PET/CT, biotechnology company experience, orphan drugs, cancer immunotherapy, chemotherapy, bone marrow transplantation, cellular and biomolecular product development, cell therapy, CAR-T treatment, cardiology, inclusive lead of clinical development strategy, collaboration with internal and external experts, develop clinical development plans, pre-clinical and clinical development, Pharmaceutical Diagnostics, clinical leadership in cross-functional projects and across regions, Pharmacovigilance, risk assessment programs, post-marketing patient safety, support reimbursement, support regulatory approval, value assessments, Investigator Sponsored Studies, Real-world evidence, evidence generation, identify innovative products, excellent communication and influencing skills, KOL engagement and trustful relationships, outstanding networking skills with internal stakeholders and external experts, team player with global mindset, independent worker, strategic management with rigor, customer savvy, conduct of compassionate use program, conduct mandatory registry, collaboration with international lymphoma alliances, work with medical services, support Public/Governmental Affairs events and involve with political stakeholders, international congresses, medical support of Marketing/Commercial/ Market Access, organize advisory boards, product launch, review of EU promotional materials, EU wide medical product expert, medical support of global projects, medical expertise to global team, safety related customer presentations including US centers, medical product specialist, medical writer, clinical research phase I-IV, observational studies, case reports, clinical experience in urology/oncology, fluency in English and French language, providing evidence to clinical guidelines , member of country and EMEA medical leadership teams, business reviews, budget management, country Senior Medical Director, Central and East Europe Medical Director, Graduate Plan Officer (Stufenplanbeauftragter), Medical Technology, Pharma, biosimilars, medical devices, connect referral and qualified centers for CAR-T treatment, Senior Clinical research Associate.

Medical Affairs Director with extensive strategic management experience including Drug Safety,and Medical Information teams and as Country Medical Director for 12 years.
Additional experience in Clinical Research and Marketing.
Graduated Plan Officer for Germany (Stufenplanbeauftragte, AMG §63a) in Pharmacovigilance Local Safety Unit for 8 years.
Offering medical support for all Medical Affairs and Product Safety related projects as well as medical assistance with Market Access/Product Launches, Pricing & Reimbursement - and beyond.
Medical service includes Pharma & Biotech, Generic Products & Biosimilars, Medical Technology/Device & Diagnostics.

have acted as member of the EMEA Medical Affairs Leadership Team and the Country Leadership Team for the last 4 years