Provide global medical leadership for the R&D function of the Fresenius Kabi MedTech business, which includes medical devices and solutions associated with transfusion, cell therapies, and infusion technology.
Participate in and guide risk management inputs for development projects, support definition and execution of clinical developments supporting new product development and product changes and contribute to post-market evaluations according to applicable regulations.
Positively impact the business relative to product development strategies, with consideration for medical benefit and value differentiation, as well resource planning and cost. As a member of the MedTech R&D leadership, participate in decision making within the business, including alignment with internal and external peers in support of MedTech R&D goals.
Your Assignments:
* Contributing to the strategic direction of Fresenius Kabi MedTech, e.g. identification and evaluation of research and development opportunities for MedTech, including identification of startups and identification of new growth areas/ new product ideas
* Management of a network of Key Opinion Leaders in science and clinic
* Approval of all clinical trials initiated or sponsored by MedTech Division
* Safety and pharmacovigilance (in cooperation with QM)
* Supervision and control of all MedTech-activities regarding medical-scientific aspects
* Support of MedTech in medical-scientific issues and decisions including product safety
* Keep the organization up-to-date with new international guidelines and support the organization by being compliant with them
* Representing Fresenius Kabi MedTech in the medical-scientific world
* Preclinical Safety and Development
* Safety and Pharmacovigilance of clinical trials including Health and Hazard Analyses (HHA)
* Global sample supply clinical trials
* Training of staff regarding QM and compliance with international guidelines
Your Profile:
* Successfully completed university degree in Natural Sciences (preferably Medicine or Pharmacy)
* At least 5 years of experience in the pharmaceutical industry (preferably in the field of MedTech)
* Experience in scientific communication as well as excellent interaction with experts, opinion leaders and stakeholders
* Excellent interviewing and presentation skills, as well as the ability to tailor complex issues to the information needs of the target audience
* Strong communication skills and very good time and self-management skills
* Excellent leadership, management, analytical, interpersonal, planning, communication, and collaboration skills
* Ability to think scientifically and analytically coupled with a strategic mindset and pragmatism
* Demonstrated cooperation within functional and cross-functional teams toward the achievement of objectives
* Ability to develop medical strategies aligned to business objectives
* Ability to demonstrate handling of multiple projects and activities at the same time
* High level of teamwork and cooperation skills
* Fluent negotiation skills in English
* Very good IT skills (MS Office applications including Word, Excel and PowerPoint)
* High willingness to travel
#J-18808-Ljbffr