Collaborating with other functional groups within the client where necessary to support milestone achievement and to manage study issues and obstacles. Consulting with pharmacogenetics experts on preclinical and medical aspects as well as side effects (including SAEs and SUSARs). Anticipating project risk and implementing mitigation strategies.
Plan and execute load assessment tasks for research, sales, and service-related projects using advanced aero-elastic simulation tools. Provide expert technical input to development projects by integrating real site-specific load insights. Prepare clear technical reports and documentation summarizing analyses and results.
You can therefore expect to: Identify user needs, design inputs and specifications through participation in the project start-up phase where interaction with key opinion leaders, doctors and other experts worldwide is crucial to fulfil the ambitious innovation targets Be a key influencer in significant development projects within Ambu, either through a mechanical design or lead role Develop new, and further improve existing, mechanical design solutions of components and assemblies as well as optimization of existing designs for Ambu's extensive product portfolio within endoscopy, anesthesiology, and patient monitoring Have the responsibility for the mechanical design and construction of functionalities, parts and assemblies including quality aspects for robust and safe medical products Translate technology concepts into fully working prototypes ready for feasibility testing and process evaluation including documentation Ensure that the component or product is manufacturable in high volume, fulfils function and stays within defined cost framework Ensure continually updated documentation in accordance with the regulations from FDA and ISO certification including FMEA's, risk assessments and tolerance analyses Trust cooperation with internal and external partners.
The Medical Strategy Lead will also be responsible for early engagement business development activities, providing scientific knowledge and expertise to guide sponsors in Cardiovascular development. As a subject matter expert, the Medical Strategy Lead will drive thought leadership activities including presentations, publications, and interactions with the medical scientific community.
The Medical Strategy Lead will also be responsible for early engagement business development activities, providing scientific knowledge and expertise to guide sponsors in CNS clinical development. As a subject matter expert, the Medical Strategy Lead will drive thought leadership activities including presentations, publications, and interactions with the medical scientific community.
You have initial experience in the functional and disciplinary leadership of a team.You demonstrate strong analytical skills, particularly in profitability analyses, general evaluations, and variance analyses.You take responsibility for international initiatives and projects, for example to optimize planning and reporting processes.You act as a strong communicator and trusted advisor as well as a central interface for executive management, the executive board, and other internal and external stakeholders.You have very strong technical expertise, especially advanced Excel skills at expert level, experience in building BI dashboards, and HR KPI management.You communicate fluently and confidently in both English and German.You have solid knowledge of SAP FI/CO, including BW.