Nick Darwall-Smith

About Nick Darwall-Smith

Leader with 25+ years of experience delivering technology, quality, and operational transformation across CROs, biotechs, and large pharma. Brings deep knowledge of clinical research technology enablement from early-stage R&D through global late-phase trials, including CTMS, eTMF, eCOA, RBQM, DCT, ERP, AI/ML, and real-world data solutions. Expert in aligning strategy, process, and technology to accelerate study start-up, improve data integrity, enhance patient and site experience, and deliver measurable ROI. Strong foundation in regulatory compliance and validation, including 21 CFR Part 11, GCP, and EU Annex 11.Track record includes developing global technology and business strategies at Parexel International for both internal operations and top-tier pharma sponsors; leading R&D IT strategy at Sana Biotechnology to enable the transition from exploratory research to GCP with compliant, scalable platforms; overhauling IT systems and SOPs at HiRO (CRO) to strengthen compliance, security, and operational efficiency; and conducting quality and compliance due diligence for private equity investments in biotech, pharma, and CRO targets at Marwood Group. Early career at Sandoz provided a solid foundation in the collection, cleaning, and integrity of clinical trial data.Recognized for building and leading high-performing global teams, influencing at all organizational levels, and managing multi-million-dollar budgets to deliver on complex, multi-stakeholder initiatives. Adept at forging partnerships across sponsors, vendors, and internal teams to drive digital innovation, operational excellence, and sustained competitive advantage in clinical research.

Experience

1. Clinical Portfolio Technologies

   Alnylam Pharmaceuticals

   Jan 2026 — Present · Cambridge, MA, US

   Defining and implementing Alnylam\'s technology strategy to enable Clinical Development.

Education

• University of London

  MSc Computer Science, specialism in Database theory

• University of Nottingham

  BSc Zoology, specialism in Neurobiology

Skills

• Data Management
• 21 Cfr Part 11
• CRO
• Good Clinical Practice (Gcp)
• Personnel Management
• Clinical Development
• Gamp
• Systems Management
• IT Solutions
• System Design
• IT Consulting
• Sarbanes-Oxley Act
• Strategic Leadership
• CRO Management
• Gcp
• Cdisc
• Vision Development
• Cdisc Standards
• Clinical Trials
• Csv
• Itil
• Cross-Functional Team Leadership
• Sdlc
• Edc
• Pharmaceutical Industry
• Sop
• Fda
• Business Intelligence
• Management
• Data Modeling
• Gxp