Senior RWE Consultant

52599
  • Europe, United States
  • Contract
Contract | Global Pharmaceutical Company
Overview
We are partnering with a large, global pharmaceutical organisation to appoint a Senior RWE Consultant to support a high-priority development programme in a new indication.
This is a strategic and execution-focused role, sitting at the intersection of real-world data acquisition, study design, and evidence generation, directly influencing clinical development and decision-making as the programme progresses towards late-stage development.

Key Responsibilities
1. Real-World Data (RWD) Strategy & Acquisition
  • Lead the prioritisation and evaluation of RWD sources to support the Indication development programme
  • Develop and present clear recommendations on optimal data sources to cross-functional stakeholders
  • Engage with external data providers to establish collaborations, negotiate access, and enable data ingestion (or external usage where appropriate)
  • Build and advise on a scalable internal RWD network, ensuring data readiness to address key research questions
  • Drive the implementation of the RWD acquisition strategy, ensuring timely access to high-quality data for analysis
2. RWE Strategy & Study Design
  • Define and develop the Real-World Evidence strategy to address key research questions, including:
    • Predictors of response and clinical outcomes
    • Dose optimisation
  • Provide expert methodological input on study design within pharmacoepidemiology
  • Design innovative and robust approaches leveraging real-world data
3. Scientific Leadership & Delivery
  • Develop concept sheets and full study protocols (minimum of two studies)
  • Lead the end-to-end development of protocols, ensuring scientific rigor and alignment with regulatory and internal expectations
  • Present protocols to internal governance committees and secure approvals
  • Generate evidence to:
    • Identify key covariates impacting efficacy endpoints
    • Inform trial design optimisation
    • Analyse patient subgroups and competitive landscape endpoints

Impact of the Role
  • Directly shape clinical development strategy for a novel indication
  • Enable data-driven decision making through robust RWE generation
  • Establish foundational RWD infrastructure to support ongoing and future research
  • Influence how evidence is generated for both regulatory and internal stakeholders

Your Profile
  • Significant experience (8+ years) within RWE, Epidemiology, or related fields in the pharmaceutical/biotech industry
  • Strong background in study design and methodology, particularly within real-world and observational research
  • Proven experience working with real-world data sources (e.g., claims, EMR, registries)
  • Experience in data acquisition, partnerships, and vendor/data holder engagement
  • Ability to operate at both strategic and hands-on levels (strategy + execution)
  • Comfortable working cross-functionally with clinical, regulatory, biostatistics, and medical teams
  • Excellent communication and stakeholder engagement skills, including presenting to governance bodies

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