Biologist, Chemist - Management Global Medical Affairs (m/f/d)

Beschreibung

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team of more than 100,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.

Location/Division Specific Information
As one of the largest biotechnology companies in Germany, we research, develop and produce innovative biomarker diagnostics and distribute our products in more than 65 countries. B•R•A•H•M•S is based in Hennigsdorf near Berlin, which is home to about 285 of the company’s 550 employees worldwide.

Discover Impactful Work:
We are looking for you to strengthen our Global Medical Affairs Biomarkers team as soon as possible. In this position you will be responsible for clinical profiling biomarkers in accordance with strategic plan, for the efficient management of all activities to facilitate creation and communication of clinical evidence and for supervision of the conduct of international multicentric clinical trials.

Responsible role in clinical research, with the potential to contribute to medical progress. You will be responsible to establish and maintain the scientific validity, clinical performance and benefits of BRAHMS biomarkers throughout their life cycle and to ensure that results of clinical trials are documented, scientifically communicated and published at congresses and in journals internationally. You will evaluate data on clinical needs of biomarkers, also in terms of achievable market success, and plan the necessary steps for clinical profiling of BRAHMS biomarkers. In close collaboration with Marketing, you define the communication strategy for clinical benefit and are responsible for clinical studies from their planning to implementation. This includes the conception, budgeting, operational implementation, and scientific exploitation of the results in compliance with valid regulations in close cooperation with Research & Development, Marketing and Regulatory Affairs. In this context, you will establish and maintain contacts with high-ranking international opinion leaders in the medical environment and build and maintain networks. Your tasks will also include training BRAHMS sales and service staff as well as the responsible sales partner staff in clinical reasoning.

Education

• Diploma/master’s degree in biology, biochemistry pharmacy or medical degree

Experience

• Minimum of 3 years of professional experience in working with biomarkers and successful track record of overseeing and conducting IVD trials
• practical knowledge in project management
• Sound knowledge of IVD-R, MPG and ICH-GCP
• Experience in dealing with regulatory authorities

Knowledge, Skills, Abilities

• Willingness to solve a wide range of tasks requiring flexible or systematic work with accurate documentation
• Very good communication skills
• High analytical skills, confident negotiation, and presentation skills
• High personal motivation and the ability to work systematically under changing demands
• Basic understanding of diagnostic biochemical or immunological procedures and own scientific publications are desired
• Fluent, business fluent English skills
• Willingness to travel 20%

• Employment with an innovative, future-oriented organisation
• Outstanding career and development prospects
• Company pension scheme and other fringe benefits
• Exciting company culture which stands for integrity, intensity, involvement and innovation