Miriam Rubelt

About Miriam Rubelt

Forward-thinking, solution-focused, and self-directed leader in precision healthcare with demonstrated success in academic research, clinical and regulatory operations, and digital data governance for translational medicine, medical devices, and AI/ML-supported software as medical devices (SaMD) seeking new opportunities to explore novel treatments and technologies which will have a sustainable impact on patient`s life and the healthcare environment. Multilingual | German, English, and FrenchWHAT DO I BRING? Provides oversight for regulatory interactions such as preparing and reviewing regulatory documents per the quality guidelines for digital products in collaboration with the regulatory team. Initiated and drove novel research strategies and led their implementation and execution. Managed the Contract Research Organization (CRO), the initial identification of suitable partners, the scope of work, and interactive management to ensure project success. Planned, implemented, and managed a system for organizing and re-defining, data use terms across the digital product portfolio.SELECTED ACCOMPLISHMENTS: Ensured adherence to regulatory requirements, ethical and scientific quality of study conduct, and industry standards compliance with ICH GCP E6, ISO 14155, and ISO/IEC 23053:2022. Grew clinical collaborations that use advanced analytics (AI/ML) to quantify surgical efficiencies and performance. Clinical studies were conducted in a timely manner and within site budgets and escalated issues to senior staff in a timely manner.Clinical | Healthcare | Pharmaceutical | Collaboration | Technical | Focused | Ecosystem | Leadership | Medical | Business Development | Collaborate | Marketing | Diagnostics | R&D | Biopharma | Communication | Hybrid | Innovation | Startups | Neurology | Cloud | Management | Patients | HCP | Payer | Ethics | Liaison | Recruit | Advocacy | Budgeting | Forecasts | Messaging | Long Range | Data Driven | Early Stage | Partnership | Promotional | Therapeutic | New Programs | Presentations | Brand Strategy | Executive Team | Code Of Conduct | Market Planning | Market Research | Drug Development | Patient Advocacy | Product Planning | Management Review | Therapeutic Areas | Board Of Directors | Market Assessments | Strategic Direction | Clinical Development | Commercial Functions | Development Programs | Development Strategy | Portfolio Management | Process Improvements | Protocol Development | Strategic Leadership | Development Opportunities | Manage | Diligence | Influence | Resolving Issues | KPIs

Experience

1. Head of Clinical Affairs

   Hyperfine | AI-Powered Portable MRI

   Sep 2024 — Present · Palo Alto, CA, US

   Playing a key role in driving the clinical strategy and operations for Hyperfine\'s groundbreaking portable MRI technology, leading a dynamic team to generate clinical evidence and expand into neurodegenerative and neurointerventional areas to revolutionize patient care. Cultivates a strategic clinical ecosystem by fostering collaborations and corporate partnerships aligned with Hyperfine\'s growth objectives. Leads and develops the Clinical teams, ensuring alignment with business, regulatory, and product objectives. Develops strategies to assess feasibility and expand clinical evidence supporting the adoption of ultra-low-field portable MRI. Collaborates cross-functionally to design studies, establish goals, timelines, and oversee progress while ensuring patient safety and regulatory compliance. Manages clinical studies with user groups to generate evidence for clinical/patient claims and hospital ROI, contributing to the growth of clinical use cases. Implements best practices for clinical study design, data collection, analysis, and regulatory compliance. Builds and sustains relationships with clinical partners and Key Opinion Leaders to optimize study design, execution, and explore new value propositions. Manages the clinical team budget, ensuring resource allocation for efficient, high-quality studies.

Education

• Humboldt-Universität zu Berlin

  Diplom, Biologie/biologische Wissenschaften, allgemein

  2002 — 2008

• Stanford University School of Medicine

  Postdoctoral Fellow, Department of Anesthesiology, Perioperative, and Pain Medicine

• Charité Berlin and Humboldt-University of Berlin

  PhD, Biology

  2008 — 2013