Analysis and reporting of clinical data for clinical development, due diligence, clinical trial design.
Aktualisiert am 08.12.2025
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Freiberufler / Selbstständiger
Remote-Arbeit
Verfügbar ab: 01.01.2026
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Klinische Entwicklung, Analyse klinischer Daten, regulatorisches Medical Writing.

Einsatzorte

Einsatzorte

Frankfurt am Main (+50km) Zürich (+10km)
Deutschland, Schweiz

Remote bevorzigt

möglich

Projekte

Projekte

7 Monate
2022-04 - 2022-10

Medizinische Beratung in der Produktkommunikatiom

Ärztlicher Berater Pharmazeutidche Medizin
Ärztlicher Berater

Europäische Produkt-PR in der Onkologie

Enhertu
Pharmazeutidche Medizin
Daiichi-Sankyo
Remote
2 Jahre 3 Monate
2019-10 - 2021-12

Analyse von Krebsregisterdaten

Ärztlicher Referent Arzt
Ärztlicher Referent

Analyzed data from the cancer registry database,
Mined various web portals for physician data,
Merged with data from statutory health insurance.

Erzeugte automatisierte Berichte auf Basis von Register- und Webdaten zur onkologischen Versorgung in Hessen

RStudio Oracle/SQL
Arzt
Hessisches Krebsregister
Frankfurt am Main
11 Monate
2018-01 - 2018-11

Exploration of new technologies for external business opportunities

Interim Senior Medical Expert in Technology Scouting
Interim Senior Medical Expert in Technology Scouting
Merz Pharmaceuticals.
9 Monate
2017-04 - 2017-12

Write clinical evaluation reports, SOP makeover and revision.

Freelance clinical expert for various CROs
Freelance clinical expert for various CROs
eg: Johner Institute for QM in the health sector (Konstanz), CRI-Clinical Research International Ltd. (Cologne)
6 Monate
2016-10 - 2017-03

Respond to EMA-questions for a new immunosuppressive drug

Senior Medical Adviser
Senior Medical Adviser
  • Respond to EMA-questions for a new immunosuppressive drug
  • Design and review pediatric investigation plans
  • Train staff, incl. statistical and medical advice.
NDA Regulatory Service in Munich
2 Jahre 3 Monate
2014-07 - 2016-09

Initial interviews with radio-chemotherapy patients

Senior House Officer
Senior House Officer
  • Initial interviews with radio-chemotherapy patients
  • On-call duty on the radio-oncology ward (50beds)
  • Quality management team for ISO9001 certification
Radio Oncology Clinic in Chemnitz
1 Jahr
2012-12 - 2013-11

Development of a graphical model validation tool and presentation

  • Development of a graphical model validation tool and presentation at an expert meeting in population pharmacokinetics
  • Courses in Population-PK/PD-Modeling/Simulation and in SAS
Consult Personaldienstleistungen AG / Frankfurt
6 Jahre 3 Monate
2006-09 - 2012-11

Different projects

Medical data review

Rolle: Medical data reviewer

Aufgaben:

  • Documented cleansing of clinical data for modeling
  • Automatized report generation.
  • Development and evaluation of a simulation-based prediction-corrected Visual Predictive Check of Model/Data correspondence

First-in-Man IND, clinical study report, CTD clinical summaries, benefits/risks analysis

Rolle: Regulatory Medical Writer

Aufgaben:

  • Drafted, reviewed, edited, and coordinated approval of:
    First-in-Man IND, clinical study report, CTD clinical summaries, benefits/risks analysis.
  • Main indications: Oncology, Metabolism, Neurology
Pop-PK Modeling (sanofi / Frankfurt)
6 Jahre 9 Monate
2003-06 - 2010-02

Statistical analysis plans for clinical trials and 3 MD-theses.

Pro bono statistician
Pro bono statistician
ENT-Clinic Dresden-Friedrichstadt
3 Jahre 3 Monate
2003-06 - 2006-08

Data Analysis, Biometry and Medical Writing

Consultant
Consultant
  • Analysis of clinical data on Sudden Sensory-Neural Hearing Loss
  • Endpoint development and sample-size estimation.
  • Presentation for Scientific Advice at BfArM.
  • Drafting and authoring of scientific manuscripts for publication
Fresenius-Kabi (until 8/2006)
1 Jahr 3 Monate
2002-03 - 2003-05

Research & Development

Head Research & Development
Head Research & Development
  • GCP-responsible for clinical studies from design to patient inclusion.
  • Controlled preclinical trials and the development of lab methods.
  • Literature analysis of the development risk.
Health Research Services Ltd.
1 Jahr 2 Monate
2001-01 - 2002-02

Design of study protocols based on given objectives

Medical Writer
Medical Writer
  • Design of study protocols based on given objectives.
  • Writing of clinical study reports according to ICH E3.
  • Drafting of scientific manuscripts for publication.
ClinResearch GmbH / Cologne
2 Jahre 3 Monate
1998-10 - 2000-12

Different projects

Clinical trials in Medical Informatics

Rolle: Medical Coordinator 
Kunde: Institute for Medical Statistics, IT, and Epidemiology 

National cancer registry and subsystem

Rolle: Administrator 
Kunde: Children' Cancer Clinic of the University Cologne

7 Jahre 6 Monate
1990-03 - 1997-08

Teaching in theoretical physics and Data Preprocessing

Assistant lecturer and guest scientist
Assistant lecturer and guest scientist
  • Teaching in theoretical physics and Data Preprocessing
  • Project leader for software development for Pattern Recognition.
4 Jahre 5 Monate
1985-10 - 1990-02

Different projects

Rolle: Consultant

Kunde: Los Alamos National Laboratory  (Theoretical Biology, T10), Los Alamos / NM.

Rolle: Visiting Assistant Professor

Kunde: Clarkson University, Potsdam / NY, lecturing Optics and Biophysics

Rolle: Research Associate

Kunde: Rockefeller University, New York, NY. (Biophysics / Statistical Mechanics)

Los Alamos National Laboratory (Theoretical Biology, T10), Los Alamos / NM.
4 Jahre 7 Monate
1981-03 - 1985-09

Science

Scientific Assistant
Scientific Assistant
ITP of the University Utrecht / NL

Aus- und Weiterbildung

Aus- und Weiterbildung

12/2013 ? 06/2014

Professional reorientation and update of my medical education

Courses at the Physicians? Academy in Bad Neuheim

Online continuing medical education at springermedizin.de

2005 ? 2007

Master study of Pharmaceutical Medicine at University Duisburg-Essen

03/1981 - 06/1985

PhD in physics and mathematics
Title: (on request)

09/1971 ? 02/1981

Study of Medicine and Physics at RWTH Aachen
Elective: Neurology at the Neurology Clinic 

03/1979

Certification as physician (Approbation als Arzt)

Additional professional qualifications

Medicine

Certificate with overview on my continuing medical education - see the link below.

Medical Biometry

2013

SAS-Institute:  Advanced SAS Programmer Package, Statistics 2

2006 ? 2011

  • Master study Medical Biometry at Ruprecht-Karl University Heidelberg Basic plus:
  • Diagnostic Studies
  • Preclinical Studies
  • Nonparametric Methods
  • Molecular Medicine
  • Multiple Testing and Group-sequential Analysis
  • Equivalence and Non-inferiority Studies
  • Health Economical Evaluation
  • Analysis of Safety Data from Clinical Trials
  • Statistical Analysis with Missing Values Using Multiple Imputation
  • Meta-analysis
  • Analysis of Longitudinal Data
  • Workshop Practical Examples in Medical Biometry

Position

Position

Due diligence analysis of clinical development data.

Study design 

Medical Technology Scouting.

Kompetenzen

Kompetenzen

Top-Skills

Klinische Entwicklung, Analyse klinischer Daten, regulatorisches Medical Writing.

Produkte / Standards / Erfahrungen / Methoden

Objective

  • Establish safety and efficacy for new drugs in an effective team.

Profile

  • Licensed physician with 18 years' experience in clinical research and recent clinical experience in radio oncology.

Regulatory writing

  • Drafting and editing of comprehensive clinical documents (IND/CTA, IMPD, IB, PSUR, Benefits/Risk, CTD summaries), study protocols and reports for mainly oncologic indications as regulatory medical writer at Sanofi and in a CRO.
  • Pediatric development plan and answering list of CHMP questions for an immunosuppressant drug as Medical Expert in a submission agency.
  • Clinical experience as a physician in chemoradiotherapy.

Clinical development

  • MSc studies Pharmaceutical Medicine (MSc-Cert.) & Medical Biometry, literature analysis, concept and realization of clinical studies as Head R&D and GCP responsible person for clinical studies.

Pharmacokinetics

  • Medical data reviewer in population-pharmacokinetics at Sanofi. Methodological work in modeling.

Regulations/GCP

  • SOP consulting for a newly founded CRO (CRI, Cologne)

Controlling

  • Medical coordination of clinical and controlling of preclinical studies at CROs incl. as head R&D at a CRO,

Presentation

  • Speaker at scientific advice with BfArM and at national expert meetings.
  • Lectured in physics, data analysis, and safety medical writing

Programmiersprachen

RStudio

Datenbanken

Oracle/SQL

Einsatzorte

Einsatzorte

Frankfurt am Main (+50km) Zürich (+10km)
Deutschland, Schweiz

Remote bevorzigt

möglich

Projekte

Projekte

7 Monate
2022-04 - 2022-10

Medizinische Beratung in der Produktkommunikatiom

Ärztlicher Berater Pharmazeutidche Medizin
Ärztlicher Berater

Europäische Produkt-PR in der Onkologie

Enhertu
Pharmazeutidche Medizin
Daiichi-Sankyo
Remote
2 Jahre 3 Monate
2019-10 - 2021-12

Analyse von Krebsregisterdaten

Ärztlicher Referent Arzt
Ärztlicher Referent

Analyzed data from the cancer registry database,
Mined various web portals for physician data,
Merged with data from statutory health insurance.

Erzeugte automatisierte Berichte auf Basis von Register- und Webdaten zur onkologischen Versorgung in Hessen

RStudio Oracle/SQL
Arzt
Hessisches Krebsregister
Frankfurt am Main
11 Monate
2018-01 - 2018-11

Exploration of new technologies for external business opportunities

Interim Senior Medical Expert in Technology Scouting
Interim Senior Medical Expert in Technology Scouting
Merz Pharmaceuticals.
9 Monate
2017-04 - 2017-12

Write clinical evaluation reports, SOP makeover and revision.

Freelance clinical expert for various CROs
Freelance clinical expert for various CROs
eg: Johner Institute for QM in the health sector (Konstanz), CRI-Clinical Research International Ltd. (Cologne)
6 Monate
2016-10 - 2017-03

Respond to EMA-questions for a new immunosuppressive drug

Senior Medical Adviser
Senior Medical Adviser
  • Respond to EMA-questions for a new immunosuppressive drug
  • Design and review pediatric investigation plans
  • Train staff, incl. statistical and medical advice.
NDA Regulatory Service in Munich
2 Jahre 3 Monate
2014-07 - 2016-09

Initial interviews with radio-chemotherapy patients

Senior House Officer
Senior House Officer
  • Initial interviews with radio-chemotherapy patients
  • On-call duty on the radio-oncology ward (50beds)
  • Quality management team for ISO9001 certification
Radio Oncology Clinic in Chemnitz
1 Jahr
2012-12 - 2013-11

Development of a graphical model validation tool and presentation

  • Development of a graphical model validation tool and presentation at an expert meeting in population pharmacokinetics
  • Courses in Population-PK/PD-Modeling/Simulation and in SAS
Consult Personaldienstleistungen AG / Frankfurt
6 Jahre 3 Monate
2006-09 - 2012-11

Different projects

Medical data review

Rolle: Medical data reviewer

Aufgaben:

  • Documented cleansing of clinical data for modeling
  • Automatized report generation.
  • Development and evaluation of a simulation-based prediction-corrected Visual Predictive Check of Model/Data correspondence

First-in-Man IND, clinical study report, CTD clinical summaries, benefits/risks analysis

Rolle: Regulatory Medical Writer

Aufgaben:

  • Drafted, reviewed, edited, and coordinated approval of:
    First-in-Man IND, clinical study report, CTD clinical summaries, benefits/risks analysis.
  • Main indications: Oncology, Metabolism, Neurology
Pop-PK Modeling (sanofi / Frankfurt)
6 Jahre 9 Monate
2003-06 - 2010-02

Statistical analysis plans for clinical trials and 3 MD-theses.

Pro bono statistician
Pro bono statistician
ENT-Clinic Dresden-Friedrichstadt
3 Jahre 3 Monate
2003-06 - 2006-08

Data Analysis, Biometry and Medical Writing

Consultant
Consultant
  • Analysis of clinical data on Sudden Sensory-Neural Hearing Loss
  • Endpoint development and sample-size estimation.
  • Presentation for Scientific Advice at BfArM.
  • Drafting and authoring of scientific manuscripts for publication
Fresenius-Kabi (until 8/2006)
1 Jahr 3 Monate
2002-03 - 2003-05

Research & Development

Head Research & Development
Head Research & Development
  • GCP-responsible for clinical studies from design to patient inclusion.
  • Controlled preclinical trials and the development of lab methods.
  • Literature analysis of the development risk.
Health Research Services Ltd.
1 Jahr 2 Monate
2001-01 - 2002-02

Design of study protocols based on given objectives

Medical Writer
Medical Writer
  • Design of study protocols based on given objectives.
  • Writing of clinical study reports according to ICH E3.
  • Drafting of scientific manuscripts for publication.
ClinResearch GmbH / Cologne
2 Jahre 3 Monate
1998-10 - 2000-12

Different projects

Clinical trials in Medical Informatics

Rolle: Medical Coordinator 
Kunde: Institute for Medical Statistics, IT, and Epidemiology 

National cancer registry and subsystem

Rolle: Administrator 
Kunde: Children' Cancer Clinic of the University Cologne

7 Jahre 6 Monate
1990-03 - 1997-08

Teaching in theoretical physics and Data Preprocessing

Assistant lecturer and guest scientist
Assistant lecturer and guest scientist
  • Teaching in theoretical physics and Data Preprocessing
  • Project leader for software development for Pattern Recognition.
4 Jahre 5 Monate
1985-10 - 1990-02

Different projects

Rolle: Consultant

Kunde: Los Alamos National Laboratory  (Theoretical Biology, T10), Los Alamos / NM.

Rolle: Visiting Assistant Professor

Kunde: Clarkson University, Potsdam / NY, lecturing Optics and Biophysics

Rolle: Research Associate

Kunde: Rockefeller University, New York, NY. (Biophysics / Statistical Mechanics)

Los Alamos National Laboratory (Theoretical Biology, T10), Los Alamos / NM.
4 Jahre 7 Monate
1981-03 - 1985-09

Science

Scientific Assistant
Scientific Assistant
ITP of the University Utrecht / NL

Aus- und Weiterbildung

Aus- und Weiterbildung

12/2013 ? 06/2014

Professional reorientation and update of my medical education

Courses at the Physicians? Academy in Bad Neuheim

Online continuing medical education at springermedizin.de

2005 ? 2007

Master study of Pharmaceutical Medicine at University Duisburg-Essen

03/1981 - 06/1985

PhD in physics and mathematics
Title: (on request)

09/1971 ? 02/1981

Study of Medicine and Physics at RWTH Aachen
Elective: Neurology at the Neurology Clinic 

03/1979

Certification as physician (Approbation als Arzt)

Additional professional qualifications

Medicine

Certificate with overview on my continuing medical education - see the link below.

Medical Biometry

2013

SAS-Institute:  Advanced SAS Programmer Package, Statistics 2

2006 ? 2011

  • Master study Medical Biometry at Ruprecht-Karl University Heidelberg Basic plus:
  • Diagnostic Studies
  • Preclinical Studies
  • Nonparametric Methods
  • Molecular Medicine
  • Multiple Testing and Group-sequential Analysis
  • Equivalence and Non-inferiority Studies
  • Health Economical Evaluation
  • Analysis of Safety Data from Clinical Trials
  • Statistical Analysis with Missing Values Using Multiple Imputation
  • Meta-analysis
  • Analysis of Longitudinal Data
  • Workshop Practical Examples in Medical Biometry

Position

Position

Due diligence analysis of clinical development data.

Study design 

Medical Technology Scouting.

Kompetenzen

Kompetenzen

Top-Skills

Klinische Entwicklung, Analyse klinischer Daten, regulatorisches Medical Writing.

Produkte / Standards / Erfahrungen / Methoden

Objective

  • Establish safety and efficacy for new drugs in an effective team.

Profile

  • Licensed physician with 18 years' experience in clinical research and recent clinical experience in radio oncology.

Regulatory writing

  • Drafting and editing of comprehensive clinical documents (IND/CTA, IMPD, IB, PSUR, Benefits/Risk, CTD summaries), study protocols and reports for mainly oncologic indications as regulatory medical writer at Sanofi and in a CRO.
  • Pediatric development plan and answering list of CHMP questions for an immunosuppressant drug as Medical Expert in a submission agency.
  • Clinical experience as a physician in chemoradiotherapy.

Clinical development

  • MSc studies Pharmaceutical Medicine (MSc-Cert.) & Medical Biometry, literature analysis, concept and realization of clinical studies as Head R&D and GCP responsible person for clinical studies.

Pharmacokinetics

  • Medical data reviewer in population-pharmacokinetics at Sanofi. Methodological work in modeling.

Regulations/GCP

  • SOP consulting for a newly founded CRO (CRI, Cologne)

Controlling

  • Medical coordination of clinical and controlling of preclinical studies at CROs incl. as head R&D at a CRO,

Presentation

  • Speaker at scientific advice with BfArM and at national expert meetings.
  • Lectured in physics, data analysis, and safety medical writing

Programmiersprachen

RStudio

Datenbanken

Oracle/SQL

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