Position:                         Project Manager Clinical Research, Germany

Reports to:                     VP R&D

The Client is a Germany based drug discovery firm developing certain compounds based upon and derived from its unique technology. The idea is to take innovative compounds to a certain stage in drug development and then share the results with a Pharma powerhouse. The Client is venture capital funded and therefore closely monitored by its investors. Possible rewards are high for every individual involved under the assumption that any one of its compounds passes registration.

Tasks:

• Develop clinical development plans, study outlines and appropriate documentation
• Design, monitor and evaluate multicenter studies for phases II and III. Ensure that those studies meet certain quality criteria and are on time
• Participate in choosing CRO’s to work with and coordinate all outside contract research
• Direct and coach study team
• Interact closely with external specialist consultants and developers in other pharmaceutical organizations
• Monitor budget, performance and timelines
• Contribute to filings in cooperation with other departments, inside and outside.

Qualification:

• Several years of job experience with a CRO or within the pharmaceutical industry, preferably in drug development, e.g. with clinical studies phases I-III
• Thorough technical and scientific knowledge base; Science degree in Medicine, Biology, Chemistry
• Experience with international regulatory environment (e.g. FDA, EMEA, AMG and ICH Guidelines).
• Familiarity with pharmacogenetics, statistics, study design
• English fluent

Personality:

• Competent business behavior
• Charismatic leadership to motivate team members across company lines and borders
• Independent working style
• Appreciate risk and chances associated with drug development