Job Description

:Position OverviewThe Collaboration Scientist will initiate and manage clinical and research collaborations at hospitals, medical centers and academic institutions globally and regionally. They will work closely with both internal and external stakeholders including Clinical and Regulatory Affairs, Innovations, Product Management, Customer Development and Key Opinion Leaders (KOLs). They will actively engage in scientific programs for Siemens Ultrasound to ensure all clinical studies are compliant per requirements from the Internal Review Board (IRB) or Ethics Committee (EC), HIPAA and GDPR. They will be responsible for generating clinical evidence that are statistically robust and admissible to both domestic and international Regulatory Authorities for product commercialization as well as pre- and post- market surveillance requirements.Responsibilities

• Forge and foster partnerships with qualified collaboration partners to evaluate prototype or newly released enhancements to Siemens ultrasound equipment in radiology and general imaging.
• Drive joint projects with collaboration partners for clinical data collection, whitepapers, scientific publications, grant and patient applications, and presentations at key conferences and webinars.
• Lead collaborative discussions involving multi-modality clinical solutions and technologies with multi-disciplinary stakeholders both internally and externally.
• Communicate with multi-disciplinary thought leaders and stakeholders, e.g., hepatologists, radiologists, cardiologist, etc., to advance product utilization and adoption.
• Provide on-site technical and clinical support as needed and together with clinical application specialists and engineers e.g., during evaluation of prototypes.
• Champion KOL management together with the marketing team as needed including providing support with internal processes and/or supporting collaboration partners/KOLs with scientific presentations and publications.
• Ensures the fit of clinical collaboration projects and partners with the product roadmap and the business strategy.
• Plans and forecasts collaboration resources and funding for the individual collaboration projects and associated activities.
• Manage and own the assigned clinical collaboration projects following the collaboration management processes and directives in alignment with legal, compliance and data privacy officers, clinical and regulatory affairs managers, logistics, and regional/local collaboration members.
• Utilize process automation, digitalization and infrastructure (MS365) for content and data management involving, but not limited to, collaboration contracts creation, storage and audits, clinical data collection, storage and audits, tracking and reporting project budget and milestones.
• Work closely with external KOL collaboration sites to ensure deliverables outlined in collaboration agreements are completed and executed appropriately, and timelines, budget and data quality are met in alignment with the product roadmaps, go-to-market strategy, and business objectives.
• Work closely with other members of the ultrasound organization on development and implementation of clinical solutions as needed.
• Maintain clinical and technical expertise in medical ultrasound technologies to support internal and external partnerships and collaborative relationships with key thought leaders for comprehensive evaluation of prototypes and new products, and generation of clinical evidence.
• Support marketing, research and development, conferences, and sales activities including educational webinars and training workshops as requested to support overall ultrasound business.
• Deliver remote and/or on-site clinical support for global luminaries and Collaboration sites as needed.
• Maintain accurate audits and budget planning with appropriate stakeholders, and communicate with Siemens internal audience and leadership in a timely manner.
• Understand data analytics, visualization and reporting, and represent Siemens US in supporting external KOL sites with clinical research, review of grant submission and letter of intent/support, statistical data analysis, scientific writing, and publications.
• Implement statistical packages and softwares including, but not limited to, R, Python, MATLAB, Mathematica, Minitab, SPSS, Microsoft Excel, Power BI and QlikView/QlikSense.
• Provide clinical and scientific guidance and training to internal and external customers including competitive intelligence and interpretation of clinical studies and evidence from systematic literature reviews and meta-analysis.
• Review and finalize project deliverables and ensure study findings are valid, reliable and admissible to regulatory authorities for successful commercialization of ultrasound products

• PhD/MS in Biomedical Engineering, Computer Science, Medicine or Health Sciences related degree with 3+ years of experience in clinical research and development; Doctorate degree with preferred experience preferably in a highly regulated medical solutions industry.
• Track record of scientific publications in peer-reviewed journals with demonstrated understanding of statistical data analysis and visualization.
• Extensive knowledge of clinical study design, collaboration and data management, external clinical site monitoring, and familiarity with clinical trial design, conduct, and oversight.
• Excellent scientific writing skills and interpersonal communication skills with ability to translate complex scientific information to audiences ranging from laymen to expert including C-Level Executives and Government Officials .
• Experience with Clinical Claims matrix designs and pre- and post- market surveillance studies.
• Knowledge in writing clinical study reports, integrated summaries of safety and performance, abstracts, manuscripts, clinical risk/benefit analyses or literature summaries.
• Knowledge of FDA and European regulations to conduct pre-market, multi-center clinical studies in cardiology, radiology and digital health (AI products) including IDE, PMA, and 510(k).
• Proven ability to work independently and in a fast-paced matrix environment, produce timely quality results on multiple concurrent projects with minimal instruction, develop collaterals and talking points with ability to engage, influence and develop customer/partner strategies.
• Strong presentation skills with demonstrated analytical, creative problem solving and structured communication skills with proven ability to handle objections and mange conflict.
• Proficient using Microsoft solutions including but not limited to MS Office apps (Excel, PowerPoint, Word), and Power Platform (Power Apps, Power BI, Power Automate).
• Proficient using statistical packages and softwares including, but not limited to, R, Python, MATLAB, Mathematica, Minitab, SPSS, Microsoft 365 apps (Excel), Microsoft Power Platform (Power BI), Tableau, QlikView and QlikSense.
• Up to 75% travel including international and weekend travel.

• Experience with Siemens collaboration management processes and Directives, and knowledge of Siemens solution and product landscape preferred with desire to identify innovative applications and develop own, creative solutions to complex problems.
• Demonstrated comprehensive understanding of the medical device development process and testing standards, experience of FDA (21 CFR 212, 21 CFR 820 etc.), EU (MDR, MDD, MEDDEV 2.7/1), ISO 14155/GCP and other regulatory standards.
• Clinical experience in Radiology, Cardiology, Point of Care, Breast imaging, Musculoskeletal imaging, 3D/4D imaging, Interventional Radiology and Digital Health.

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