(Clinical) Research and Development
Research & Development
The term, pharmaceutical research, refers to the specific research for new pharmaceuticals, new pharmaceutical combinations, new pharmaceutical forms, new applications for existing products and to the development of new pharmaceuticals. The areas of research in biotechnology, medicine and pharmacy overlap to a large extent. Biotechnology is often the basis for the development of new pharmaceuticals.
In preclinical research new compounds are tested in a test tube (in vitro) or on a living object (animal studies).
Required qualifications
- In general academic degree
- Prevalently physicians or pharmacists, as well as biologists, chemists, veterinarians
- Engineers for process engineering, biotechnology, etc.
Job profiles (examples)
- Expert for Pharmaceutical Development
- Expert for Galenic Formulation
- Research Scientist
- Expert for Analytical Development
- Project Manager
- Toxicologist
- Pharmacologist
The new found substances must be tested for quality, efficacy and innocuousness in mandatory preclinical and clinical studies (preclinical, clinical trials), before they are approved by the regulatory authorities for marketing.
Clinical Research
Clinical research is a continuation of the preclinical phase and is an important process concerning the approval and surveillance of pharmaceuticals. In studies, efficacy, tolerability and safety of new and approved pharmaceuticals and treatment methods are reviewed.
Before registration, Phases I-III are distinguished and Phase IV follows after approval.
Required qualifications
- In general academic degree
- Prevalently physicians or pharmacists, as well as biologists, chemists, veterinarians
Job profiles (examples)
- Clinical Project Manager
- Clinical Study Manager
- Clinical Trial Manager
- Clinical Development Manager
- CRA
- Senior CRA
- Lead CRA
- Medical Writer
- Outsourcing & Contracts Manager
Biostatistics
For the planning and evaluation of studies, not only scientists, but also mathematicians, statisticians and programmers are often needed
Required qualifications
- Mathematicians, computer scientists and biologists with an appropriate additional qualification
- (Bio) - Statistician
- (Bio) - Computer Scientist
Job profiles (examples)
- Bio - Statistician
- Bio - Computer Scientist
- Clinical Data Manager
- Oracle Clinical Specialist
- SAS Programmer