Medical Affairs, Pharmakovigilanz, Clinical Research, Pharma, MedTech, Onkologie, Neurologie/Neuropsychiatrie, Diagnostik, Therapie
Aktualisiert am 08.12.2025
Profil
Freiberufler / Selbstständiger
Remote-Arbeit
Verfügbar ab: 15.12.2025
Verfügbar zu: 100%
davon vor Ort: 40%
Medical Affairs
Onkologie
Arzneimittelsicherheit
Urologie
Hämatologie
KOL Management
Molekulare Bildgebung
Nuklearmedizin
Immunotherapie
MSL
Blasenkarzinom
orphan drugs
ATMP
Klinische Forschung
post-marketing Studien
global teamwork
medical devices
real-worl evidence
Investigator Sponsored Studies
congress reports
medical training
advisory boards
guidelines
German
Native
English
Fluent
French
Fluent
Italian
Semi-fluent

Einsatzorte

Einsatzorte

Deutschland, Schweiz, Österreich
möglich

Projekte

Projekte

11 Monate
2025-04 - heute

Medical Affairs

Director
Director

  • Member of (on request)
  • Focused on the value maximization of current and future Medical Affairs people, processes, strategies and cross-BU product portfolio in close cooperation with Country/Region BUs and Central Medical Affairs functions.
  • Provision of medically relevant support to continue to deliver innovative, safe and efficacious solutions for patients and BD customers.

on request
Central & Eastern Europe
3 Jahre 3 Monate
2022-01 - 2025-03

Medical Affairs

Senior Director
Senior Director

  • Leading a team of 15 people (scientific field team and office-based medical managers) Responsibility for the medical budget
  • Focus on medical support of market access projects for orphan drugs (medical project lead of one mandatory registry and successful avoidance of a further registry, four value assessments, AMNOG/ pricing), attendance of exchange and hearings with German reimbursement authorities like IQWIG and G-BA
  • Conduct of a compassionate use program (medical decision on patient eligibility as pre-defined with PEI)
  • Built scientific collaboration with the most important German external research group for aggressive lymphoma (German Lymphoma Alliance), regular meetings with German HCP/therapeutic area leads
  • Mediation of the global study program in Germany with Clinical Development, receive and mediate proposals for the External Research Program from German researchers, generation of real-world evidence with high strategic impact for reimbursement and beyond
  • Flawless conduct of EMA Risk Minimisation Management Program
  • Regular data exchange with Kompetenz-Centrum Onkologie (KCO) for patient groups in need for reimbursement
  • Connection of referral and qualified centers, educational events & best practice sharing to facilitate patient pathway
  • Support of network initiatives of HCP and political stakeholders to enable patient access to cell therapy in Germany in public panels with wide media reach
  • Regular attendance of all relevant medical congresses for cell therapy ? national and international incl. US Strong contribution to medical strategy plans of the local and global team, to business reviews, to local and global leadership meetings
  • Building of a highly competent, fit and innovative medical launch team and successful implementation of two product launches
  • Constant close cross-functional collaboration with the teams from Marketing, Commercial, Market Access, Governmental Affairs and Public Affairs, providing high-quality medical support. Resulting in several innovative and fruitful projects, including patient engagement and publications

on request
4 Jahre 9 Monate
2017-04 - 2021-12

Medical Affairs, Pharmaceutical Diagnostics GE Healthcare

Medical Director
Medical Director

  • Building and leading a Medical Affairs team of 7 direct reports, including Local Safety Unit and management of remote team. 
  • Graduated Plan Officer (Stufenplanbeauftragte) for Germany, Nuclear Medicine & Radiology products (09/2013 ? 02/2021)
  • Valued medical guidance of product launches, a.o. in Gastroenterology, Oncology and Cardiology. Single medical point of contact and relationship development with key medical experts with focus on Nephrology, Oncology and Cardiology. 
  • Presenting medical data to guideline committees. Organizing and chairing of Advisory Boards in Oncology and Neurology. 
  • Medical supervision of a safety related product withdrawal process. 
  • Successful resolution of competitor objections concerning promotional materials.

on request
3 Jahre 6 Monate
2013-11 - 2017-04

Medical Affairs, Life Sciences

Medical Director D/A/CH
Medical Director D/A/CH

  • Responsibility for and optimization of a Medical Affairs team of 4 direct reports, including Local Safety Unit. 
  • Parallel 6-year role of European Medical Expert in Neurology (2 products, Parkinson Syndromes and Dementia). 
  • International scientific relationship management with focus on Neurology.
  •  Medical concept, creation, medical review and signatory for EU promotional materials.
  • Medical support of global projects and medical expertise to Global team. Support of EU congresses.

GE Healthcare
5 Jahre 9 Monate
2008-03 - 2013-11

Medical Diagnostics

Associate Medical Director, European Medical Expert
Associate Medical Director, European Medical Expert
  • Associate Medical Director Parallel 7-year role as European Medical Expert for Urology/Oncology (fluorescence cystoscopy in bladder cancer). 
  • KOL management with focus on Urology/Oncology. 
  • Support of global congresses and conduct of registry studies. 
  • On-site stepping up for the US Medical Affairs team to support US HCP connected to a product issue. Continuous focus on around 20 products in various clinical areas of the business.
  • Deputy PV Responsible Person for Austria (01/2005 - 07/2019).
  • Deputy Graduated Plan Officer (Stellvertretende Stufenplanbeauftragte) for Germany (01/2005 - 08/2013).
GE Healthcare

Aus- und Weiterbildung

Aus- und Weiterbildung

1984 - 11/1988

Medical Studies

Degree: Dr. med.

University Clinic of Essen


Key Focus:

thesis on request


1982 - 1984

Preclinical Medical Studies

Ruhr-University Bochum

Kompetenzen

Kompetenzen

Top-Skills

Medical Affairs Onkologie Arzneimittelsicherheit Urologie Hämatologie KOL Management Molekulare Bildgebung Nuklearmedizin Immunotherapie MSL Blasenkarzinom orphan drugs ATMP Klinische Forschung post-marketing Studien global teamwork medical devices real-worl evidence Investigator Sponsored Studies congress reports medical training advisory boards guidelines

Aufgabenbereiche

  • Radiology:
    • mainly CT, MRI, cardiac Ultrasound incl. a pharmacological stress agent. Diagnostic imaging during interventions (e.g. EVAR)
  • Nuclear Medicine:
    • molecular imaging, PET and SPECT for early detection and treatment monitoring (Flutemetamol/Alzheimer`s Disease, dopamine transporter SPECT/Parkinson`s disease, Tetrofosmin/cardiac imaging, incl. quantification software, image reader training, generators
  • Urology/ Oncology:
    • mainly bladder cancer and prostate cancer incl. seed implants, hormone ablation therapy and internal radiotherapy of bone metastases
  • Neurology:
    • Parkinson Syndromes (differential diagnosis)
  • Neuropsychiatry:
    • Alzheimer`s Dementia (ß-amyloid plaque imaging), Lewy Body Dementia
  • Gastroenterology:
    • measurement of Bile Acid Malabsorption
  • Oncology:
    • immuno-diagnostics targeted at PD-L1/Granzyme B/CD8+ T-cells, Estrogen Receptor PET in breast cancer, PET in non-small cell lung cancer, Sentinel Lymph Node imaging in different primary tumors, various chemotherapeutic regimen, interleukins, IFN,GM-CSF in various tumors, Flutamide (non-steroidal antiandrogen) in prostate cancer
  • Cardiology:
    • incl. Fractional Flow Reserve measurement and a contrast medium saving medical device during coronary interventions, TAVI - diagnostic imaging, Nuclear Cardiology.
  • Cell Therapy/CAR T:
    • indications aALL (adult Acute Lymphatic Leukemia), MCL (Mantle Cell Lymphoma), MM (Multiple Myeloma), DLBCL (Diffuse Large B-Cell Lymphoma). Therapeutic schemes and diagnostics (e.g. flow cytometry, liquid biopsy)
  • Medical Technology/Devices:
    • ?broad spectrum of innovative products including connected medication management (e.g. automated medication dispensing systems) and medical delivery solutions (e.g. Peripheral Venous Catheters, Peripherally Inserted Central Venous Catheters, Midline Catheters), hemodynamic monitoring, female external catheter, sterile device for skin preparation, vacuum biopsy
  • Experience in Clinical Research:
    • Over 20 years of experience with comprehensive training in Clinical Research and GCP.
    • Senior Clinical Research Associate for Phase II?IV clinical studies; supervised two clinical study monitors. Project Physician for 15 international multicenter and local studies. 
    • Collaborated closely with the global Clinical Research team on study planning, study protocol and execution. 
    • Advised on investigator selection and served as the primary local contact during study negotiations and conduct. Developed study protocols in collaboration with clinical experts for 5 local studies.
    • Developed study protocols for Phase I (bioavailability) and Phase III (cardiovascular) studies. 
    • Fully implemented, conducted, and monitored projects, including budget management.
    • Provided medical support for post-marketing study planning and evidence-gap projects. Oversaw post-marketing surveillance programs and safety reporting.
    • Reviewed Investigator-Sponsored Study proposals.
    • Authored internal medical expert summaries for new products based on comprehensive study data review.

Produkte / Standards / Erfahrungen / Methoden

Profile

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.

Einsatzorte

Einsatzorte

Deutschland, Schweiz, Österreich
möglich

Projekte

Projekte

11 Monate
2025-04 - heute

Medical Affairs

Director
Director

  • Member of (on request)
  • Focused on the value maximization of current and future Medical Affairs people, processes, strategies and cross-BU product portfolio in close cooperation with Country/Region BUs and Central Medical Affairs functions.
  • Provision of medically relevant support to continue to deliver innovative, safe and efficacious solutions for patients and BD customers.

on request
Central & Eastern Europe
3 Jahre 3 Monate
2022-01 - 2025-03

Medical Affairs

Senior Director
Senior Director

  • Leading a team of 15 people (scientific field team and office-based medical managers) Responsibility for the medical budget
  • Focus on medical support of market access projects for orphan drugs (medical project lead of one mandatory registry and successful avoidance of a further registry, four value assessments, AMNOG/ pricing), attendance of exchange and hearings with German reimbursement authorities like IQWIG and G-BA
  • Conduct of a compassionate use program (medical decision on patient eligibility as pre-defined with PEI)
  • Built scientific collaboration with the most important German external research group for aggressive lymphoma (German Lymphoma Alliance), regular meetings with German HCP/therapeutic area leads
  • Mediation of the global study program in Germany with Clinical Development, receive and mediate proposals for the External Research Program from German researchers, generation of real-world evidence with high strategic impact for reimbursement and beyond
  • Flawless conduct of EMA Risk Minimisation Management Program
  • Regular data exchange with Kompetenz-Centrum Onkologie (KCO) for patient groups in need for reimbursement
  • Connection of referral and qualified centers, educational events & best practice sharing to facilitate patient pathway
  • Support of network initiatives of HCP and political stakeholders to enable patient access to cell therapy in Germany in public panels with wide media reach
  • Regular attendance of all relevant medical congresses for cell therapy ? national and international incl. US Strong contribution to medical strategy plans of the local and global team, to business reviews, to local and global leadership meetings
  • Building of a highly competent, fit and innovative medical launch team and successful implementation of two product launches
  • Constant close cross-functional collaboration with the teams from Marketing, Commercial, Market Access, Governmental Affairs and Public Affairs, providing high-quality medical support. Resulting in several innovative and fruitful projects, including patient engagement and publications

on request
4 Jahre 9 Monate
2017-04 - 2021-12

Medical Affairs, Pharmaceutical Diagnostics GE Healthcare

Medical Director
Medical Director

  • Building and leading a Medical Affairs team of 7 direct reports, including Local Safety Unit and management of remote team. 
  • Graduated Plan Officer (Stufenplanbeauftragte) for Germany, Nuclear Medicine & Radiology products (09/2013 ? 02/2021)
  • Valued medical guidance of product launches, a.o. in Gastroenterology, Oncology and Cardiology. Single medical point of contact and relationship development with key medical experts with focus on Nephrology, Oncology and Cardiology. 
  • Presenting medical data to guideline committees. Organizing and chairing of Advisory Boards in Oncology and Neurology. 
  • Medical supervision of a safety related product withdrawal process. 
  • Successful resolution of competitor objections concerning promotional materials.

on request
3 Jahre 6 Monate
2013-11 - 2017-04

Medical Affairs, Life Sciences

Medical Director D/A/CH
Medical Director D/A/CH

  • Responsibility for and optimization of a Medical Affairs team of 4 direct reports, including Local Safety Unit. 
  • Parallel 6-year role of European Medical Expert in Neurology (2 products, Parkinson Syndromes and Dementia). 
  • International scientific relationship management with focus on Neurology.
  •  Medical concept, creation, medical review and signatory for EU promotional materials.
  • Medical support of global projects and medical expertise to Global team. Support of EU congresses.

GE Healthcare
5 Jahre 9 Monate
2008-03 - 2013-11

Medical Diagnostics

Associate Medical Director, European Medical Expert
Associate Medical Director, European Medical Expert
  • Associate Medical Director Parallel 7-year role as European Medical Expert for Urology/Oncology (fluorescence cystoscopy in bladder cancer). 
  • KOL management with focus on Urology/Oncology. 
  • Support of global congresses and conduct of registry studies. 
  • On-site stepping up for the US Medical Affairs team to support US HCP connected to a product issue. Continuous focus on around 20 products in various clinical areas of the business.
  • Deputy PV Responsible Person for Austria (01/2005 - 07/2019).
  • Deputy Graduated Plan Officer (Stellvertretende Stufenplanbeauftragte) for Germany (01/2005 - 08/2013).
GE Healthcare

Aus- und Weiterbildung

Aus- und Weiterbildung

1984 - 11/1988

Medical Studies

Degree: Dr. med.

University Clinic of Essen


Key Focus:

thesis on request


1982 - 1984

Preclinical Medical Studies

Ruhr-University Bochum

Kompetenzen

Kompetenzen

Top-Skills

Medical Affairs Onkologie Arzneimittelsicherheit Urologie Hämatologie KOL Management Molekulare Bildgebung Nuklearmedizin Immunotherapie MSL Blasenkarzinom orphan drugs ATMP Klinische Forschung post-marketing Studien global teamwork medical devices real-worl evidence Investigator Sponsored Studies congress reports medical training advisory boards guidelines

Aufgabenbereiche

  • Radiology:
    • mainly CT, MRI, cardiac Ultrasound incl. a pharmacological stress agent. Diagnostic imaging during interventions (e.g. EVAR)
  • Nuclear Medicine:
    • molecular imaging, PET and SPECT for early detection and treatment monitoring (Flutemetamol/Alzheimer`s Disease, dopamine transporter SPECT/Parkinson`s disease, Tetrofosmin/cardiac imaging, incl. quantification software, image reader training, generators
  • Urology/ Oncology:
    • mainly bladder cancer and prostate cancer incl. seed implants, hormone ablation therapy and internal radiotherapy of bone metastases
  • Neurology:
    • Parkinson Syndromes (differential diagnosis)
  • Neuropsychiatry:
    • Alzheimer`s Dementia (ß-amyloid plaque imaging), Lewy Body Dementia
  • Gastroenterology:
    • measurement of Bile Acid Malabsorption
  • Oncology:
    • immuno-diagnostics targeted at PD-L1/Granzyme B/CD8+ T-cells, Estrogen Receptor PET in breast cancer, PET in non-small cell lung cancer, Sentinel Lymph Node imaging in different primary tumors, various chemotherapeutic regimen, interleukins, IFN,GM-CSF in various tumors, Flutamide (non-steroidal antiandrogen) in prostate cancer
  • Cardiology:
    • incl. Fractional Flow Reserve measurement and a contrast medium saving medical device during coronary interventions, TAVI - diagnostic imaging, Nuclear Cardiology.
  • Cell Therapy/CAR T:
    • indications aALL (adult Acute Lymphatic Leukemia), MCL (Mantle Cell Lymphoma), MM (Multiple Myeloma), DLBCL (Diffuse Large B-Cell Lymphoma). Therapeutic schemes and diagnostics (e.g. flow cytometry, liquid biopsy)
  • Medical Technology/Devices:
    • ?broad spectrum of innovative products including connected medication management (e.g. automated medication dispensing systems) and medical delivery solutions (e.g. Peripheral Venous Catheters, Peripherally Inserted Central Venous Catheters, Midline Catheters), hemodynamic monitoring, female external catheter, sterile device for skin preparation, vacuum biopsy
  • Experience in Clinical Research:
    • Over 20 years of experience with comprehensive training in Clinical Research and GCP.
    • Senior Clinical Research Associate for Phase II?IV clinical studies; supervised two clinical study monitors. Project Physician for 15 international multicenter and local studies. 
    • Collaborated closely with the global Clinical Research team on study planning, study protocol and execution. 
    • Advised on investigator selection and served as the primary local contact during study negotiations and conduct. Developed study protocols in collaboration with clinical experts for 5 local studies.
    • Developed study protocols for Phase I (bioavailability) and Phase III (cardiovascular) studies. 
    • Fully implemented, conducted, and monitored projects, including budget management.
    • Provided medical support for post-marketing study planning and evidence-gap projects. Oversaw post-marketing surveillance programs and safety reporting.
    • Reviewed Investigator-Sponsored Study proposals.
    • Authored internal medical expert summaries for new products based on comprehensive study data review.

Produkte / Standards / Erfahrungen / Methoden

Profile

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.

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