Drugs and Devices * Strategy * Science * Research * Development * Operations * Medical * Safety * Life-Cycle-Management
Aktualisiert am 07.06.2024
Profil
Freiberufler / Selbstständiger
Verfügbar ab: 09.06.2024
Verfügbar zu: 60%
davon vor Ort: 10%

Einsatzorte

Einsatzorte

Deutschland, Österreich, Schweiz
nicht möglich

Projekte

Projekte

5 Jahre 5 Monate
2019-01 - heute

Consultant for Health

Independent Business Consultant for Health
Independent Business Consultant for Health
Mainz, Germany
6 Monate
2018-07 - 2018-12

Life Cycle Management

Senior Medical Director
Senior Medical Director
Merck KGaA
Darmstadt, Germany
3 Jahre
2015-07 - 2018-06

Clinical Research

Head of Clinical Research
Head of Clinical Research
Basilea Pharmaceutica International
Basel, Switzerland
1 Jahr 9 Monate
2013-10 - 2015-06

Medical and Safety Services

Medical Director, Global Head
Medical Director, Global Head
ICON Clinical Research
Langen, Germany
1 Jahr 10 Monate
2011-12 - 2013-09

Clinical Development & Operations

Head of Clinical Development & Operations
Head of Clinical Development & Operations
Otsuka Frankfurt Research Institute
Frankfurt, Germany
5 Jahre 2 Monate
2006-10 - 2011-11

Medical and Safety Services

Medical Director
Medical Director
ICON Clinical Research
Langen, Germany
1 Jahr 9 Monate
2005-01 - 2006-09

Clinical Operations

Senior Project Manager
Senior Project Manager
Premier Research Group
Darmstadt, Germany
10 Monate
2002-09 - 2003-06

Medical Advice

Medical Advisor
Medical Advisor
Boehringer Ingelheim Pharma GmbH
Ingelheim, Germany

Aus- und Weiterbildung

Aus- und Weiterbildung

1987 - 1993
Study of Medicine at Julius-Maximilians-University Wuerzburg, Germany

Doctoral thesis:

[on request]

Position

Position

  • Strong medical background. 
  • 15 years in CRO business, pharma & biotech. 
  • Thorough knowledge of the global drug development process, FDA, EMA and other regulations as well as ICH-GCP and GVP/ PV.
  • Strong collaboration skills, team-building, communication and organizational skills.
  • Taking leadership roles and driving quality progress.
  • Identifying, negotiating and overseeing outsourced services.
  • Identifying TPPs and aligning commercial strategies.
  • Project tracking, financial budgeting and reporting.
  • Effective management of crisis and other emergent situations.
  • Entrepreneurial spirit with can do attitude, commitment to goals, and initiative.

Kompetenzen

Kompetenzen

Produkte / Standards / Erfahrungen / Methoden

  • Drugs and Devices
  • Strategy
  • Science
  • Research
  • Development
  • Operations Medical
  • Safety
  • Life-Cycle-Management

Skills

  • Strong medical background
  • 15 years in CRO business, pharma & biotech
  • Thorough knowledge of the global drug development process, FDA, EMA and other regulations as well as ICH-GCP and GVP/ PV.
  • Strong collaboration skills, team-building, communication and organizational skills.
  • Taking leadership roles and driving quality progress.
  • Identifying, negotiating and overseeing outsourced services.
  • Identifying TPPs and aligning commercial strategies.
  • Project tracking, financial budgeting and reporting.
  • Effective management of crisis and other emergent situations.
  • Entrepreneurial spirit with can do attitude, commitment to goals, and initiative.

Summary

  • 10 years? experience as a physician/ anesthetist ? 15 years? experience in the pharmaceutical industry.
  • Highly experienced cross-functional team leader and player. Strong background in cross-functional global project management. Track record in people management across different cultures, team building and excellent motivational skills.
  • Expert knowledge in business-driven global drug development/ lifecycle management/ medical affairs as well as in national and international regulatory requirements and PV regulations.
  • Direct involvement into interactions with regulatory agencies. Responsible for identification and management of KOLs and Advisory Board members incl. IDMCs and DRCs.
  • Planning and coordinating all drug development activities, compliance focused vendor management, oversight, tracking, and client focused reporting of results.
  • Acting as EU-QPPV and PV Consultant. Medical Expert in different therapeutic areas (CV, CNS, infectious diseases, oncology, immunology, diabetes, respiratory, pain, and medical devices).
  • Excellent communication and presentation skills, good problem identification and solving skills, ability to work under stressed situations as per timelines and budget.
  • Proficient IT skills and a competent knowledge of medical informatics and health economics. Expert skills in data mining, data analysis and data interpretation.
  • Speaker on various congresses and conferences.

Professional Background

2012 - today

Senior Fellow of the New Westminster College, Vancouver, British Columbia (FNWC)

1995 - today

Working as an emergency physician in the rescue and ambulance system

1994 - 2004

Hospitals in Germany
Board certification in Anaesthesiology, Emergency Medicine and Medical Informatics

Branchen

Branchen

Pharma, Biotech and Medical Devices

Einsatzorte

Einsatzorte

Deutschland, Österreich, Schweiz
nicht möglich

Projekte

Projekte

5 Jahre 5 Monate
2019-01 - heute

Consultant for Health

Independent Business Consultant for Health
Independent Business Consultant for Health
Mainz, Germany
6 Monate
2018-07 - 2018-12

Life Cycle Management

Senior Medical Director
Senior Medical Director
Merck KGaA
Darmstadt, Germany
3 Jahre
2015-07 - 2018-06

Clinical Research

Head of Clinical Research
Head of Clinical Research
Basilea Pharmaceutica International
Basel, Switzerland
1 Jahr 9 Monate
2013-10 - 2015-06

Medical and Safety Services

Medical Director, Global Head
Medical Director, Global Head
ICON Clinical Research
Langen, Germany
1 Jahr 10 Monate
2011-12 - 2013-09

Clinical Development & Operations

Head of Clinical Development & Operations
Head of Clinical Development & Operations
Otsuka Frankfurt Research Institute
Frankfurt, Germany
5 Jahre 2 Monate
2006-10 - 2011-11

Medical and Safety Services

Medical Director
Medical Director
ICON Clinical Research
Langen, Germany
1 Jahr 9 Monate
2005-01 - 2006-09

Clinical Operations

Senior Project Manager
Senior Project Manager
Premier Research Group
Darmstadt, Germany
10 Monate
2002-09 - 2003-06

Medical Advice

Medical Advisor
Medical Advisor
Boehringer Ingelheim Pharma GmbH
Ingelheim, Germany

Aus- und Weiterbildung

Aus- und Weiterbildung

1987 - 1993
Study of Medicine at Julius-Maximilians-University Wuerzburg, Germany

Doctoral thesis:

[on request]

Position

Position

  • Strong medical background. 
  • 15 years in CRO business, pharma & biotech. 
  • Thorough knowledge of the global drug development process, FDA, EMA and other regulations as well as ICH-GCP and GVP/ PV.
  • Strong collaboration skills, team-building, communication and organizational skills.
  • Taking leadership roles and driving quality progress.
  • Identifying, negotiating and overseeing outsourced services.
  • Identifying TPPs and aligning commercial strategies.
  • Project tracking, financial budgeting and reporting.
  • Effective management of crisis and other emergent situations.
  • Entrepreneurial spirit with can do attitude, commitment to goals, and initiative.

Kompetenzen

Kompetenzen

Produkte / Standards / Erfahrungen / Methoden

  • Drugs and Devices
  • Strategy
  • Science
  • Research
  • Development
  • Operations Medical
  • Safety
  • Life-Cycle-Management

Skills

  • Strong medical background
  • 15 years in CRO business, pharma & biotech
  • Thorough knowledge of the global drug development process, FDA, EMA and other regulations as well as ICH-GCP and GVP/ PV.
  • Strong collaboration skills, team-building, communication and organizational skills.
  • Taking leadership roles and driving quality progress.
  • Identifying, negotiating and overseeing outsourced services.
  • Identifying TPPs and aligning commercial strategies.
  • Project tracking, financial budgeting and reporting.
  • Effective management of crisis and other emergent situations.
  • Entrepreneurial spirit with can do attitude, commitment to goals, and initiative.

Summary

  • 10 years? experience as a physician/ anesthetist ? 15 years? experience in the pharmaceutical industry.
  • Highly experienced cross-functional team leader and player. Strong background in cross-functional global project management. Track record in people management across different cultures, team building and excellent motivational skills.
  • Expert knowledge in business-driven global drug development/ lifecycle management/ medical affairs as well as in national and international regulatory requirements and PV regulations.
  • Direct involvement into interactions with regulatory agencies. Responsible for identification and management of KOLs and Advisory Board members incl. IDMCs and DRCs.
  • Planning and coordinating all drug development activities, compliance focused vendor management, oversight, tracking, and client focused reporting of results.
  • Acting as EU-QPPV and PV Consultant. Medical Expert in different therapeutic areas (CV, CNS, infectious diseases, oncology, immunology, diabetes, respiratory, pain, and medical devices).
  • Excellent communication and presentation skills, good problem identification and solving skills, ability to work under stressed situations as per timelines and budget.
  • Proficient IT skills and a competent knowledge of medical informatics and health economics. Expert skills in data mining, data analysis and data interpretation.
  • Speaker on various congresses and conferences.

Professional Background

2012 - today

Senior Fellow of the New Westminster College, Vancouver, British Columbia (FNWC)

1995 - today

Working as an emergency physician in the rescue and ambulance system

1994 - 2004

Hospitals in Germany
Board certification in Anaesthesiology, Emergency Medicine and Medical Informatics

Branchen

Branchen

Pharma, Biotech and Medical Devices

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