- 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