JOB DESCRIPTION
Job Responsibilities
Owns and drives end‑to‑end clinical evidence strategy, defining and linking clinical need, value, TPP, claims, endpoints, and evidence to regulatory acceptance and post‑market requirements with full lifecycle traceability (AD → PDLM → PMS).
Leads clinical development in cross‑functional AD and PDLM core teams and drives program governance and cross‑project integration enabling global alignment.
Owns clinical study design, protocol development, and execution—driving end‑to‑end delivery (kick‑off to results) with optimal data strategy, data integrity, audit readiness, and proactive risk and timeline management.
Leads site/KOL engagement and all site‑facing activities (protocol communication, contracts, training) in collaboration with Clinical Science/CPM to ensure compliant execution, protocol adherence, and consistent understanding of product and data requirements.
Owns end‑to‑end data strategy and oversees data management in collaboration with data/engineering teams, ensuring data quality, completeness, annotation integrity, adherence to protocol and traceability, while resolving complex data challenges.
Collaborates with data/engineering teams on data infrastructure (catalogues, systems) for structured access, traceability.
Operationalizes real‑world data by identifying, integrating, and governing (data relevance, reliability and scientific validity) diverse data sources, and leads CER and PMCF analytics to generate and continuously assess clinical evidence on safety, performance, and benefit–risk for patient safety and in accordance with regulations and guidance documents.
Defines claims validation strategies and leads continuous post‑market evidence surveillance (PMCF/PMS), translating insights into updated claims, regulatory submissions, and expansion of clinical value, indications, and market positioning.
Authors and oversees core clinical and regulatory documents (study protocols, CDMA, data strategies, CSRs, CERs, PMCF), ensuring compliant, evidence‑based, and traceable outputs, including integration into IFU and regulatory submissions (e.g., 510k, Technical Documentation, NMPA etc).
Drives program risk management and knowledge sharing to optimize execution and evidence generation, and bridges regional and global teams.
Communicates insights and aligns stakeholders, builds KOL partnerships, and supports informed decision‑making.
Drives scientific dissemination by translating clinical and real‑world evidence into publications, presentations, and competitive insights.
Drives structured project management via ADO/Azure, aligning cross‑functional tasks, tracking dependencies, and ensuring clear ownership, prioritization, and timely execution.
You're the right fit if you have:
Medical degree (physician) / Doctor of Medicine, or Medical Technical degree, or a Life Science degree, or a Quantitative Science degree (e.g., Medicine, Technical Medicine, Biomedical Engineering, Biotechnology, Epidemiology, Health Informatics, Data Science).
Residency & Advanced Training in Diagnostic Radiology/Ultrasound domain
Experience with ultrasound imaging.
Experience with developing AI-features in Radiology/Ultrasound.
Experience with developing AI‑based medical devices.
Experience in Clinical Development / Clinical Research.
Experience in clinical evidence communication, research and analysis.
Experience in Medical Writing (CER, CSR, PMCF) and/or Scientific Publications is nice to have
Experience in MedTech, Healthcare Research, Real-World data analytics, Epidemiology, or related fields.
Experienced in regulatory compliance, process improvement and project management
Experience with data tools (R, Python, Power BI, Tableau, Git) is nice to have
Preferred Skills:
• Regulatory Compliance
• Clinical Evaluation and PMCF methodologies
• Clinical Evidence Generation Strategy
• Medical and Regulatory Writing (CER, CSR, reports)
• Data Analysis and Interpretation
• Quantitative and Real‑World Evidence Methods
• Project and Program Management
• Strategic Planning and Business Acumen
• KPI and Performance Management
• Document Review and Audit Readiness
• Continuous Improvement
• Medical Terminology
How we work together
We believe that we are better together than apart. For this role, this means working in-person at least 3 days per week.
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