Real World Evidence Lead, GRD

This is what you will do

Within the Global Rare Diseases Global Medical Affairs, reporting to the Head of Real World Evidence, the Real World Evidence Lead is responsible for shaping and executing the organisation’s RWE vision. This position focuses on building and improving RWE capabilities, establishing robust processes, and driving impactful evidence generation in collaboration with internal and external partners. The role emphasises strategic planning, change management, and oversight of studies conducted through CROs.

You will be responsible for

• Strategic Leadership & IEGP – Lead development and implementation of RWE strategies and methodologies aligned with Integrated Evidence Generation Planning across our HIDO portfolio – Hematology, Dermatology, Immunology & Ophthalmology
• RWE Start-Up & Capability Building – Establish and continuously improve RWE capabilities, processes, and infrastructure to support global and local evidence generation. Act as a change agent, effectively communicating the value of RWE and influencing adoption of new processes and approaches
• Study Oversight with CROs – Provide strategic oversight for design, initiation, and execution of RWE studies managed by CROs, ensuring quality and compliance
• Concept Reviews – Lead and participate in concept reviews for proposed RWE studies, ensuring alignment with scientific and business objectives

You will need to have

• Advanced degree (e.g., MSc, PhD, PharmD, DrPH, MD) in epidemiology, public health, health economics, or related field. A clinical background should be supplemented with advanced quantitative training in data science, biomedical informatics, health informatics, clinical informatics, epidemiology, biostatistics, health economics and outcomes research, engineering or a related field required.
• Significant experience in RWE, observational research, or related disciplines within the pharmaceutical/biotech industry or CRO environment.
• Demonstrated ability to lead and execute RWE projects and manage external partners with minimal, or no, supervision using real-world data from claims, electronic health records, registries, biobanks, and/or digital applications.
• Proven track record in establishing or improving RWE capabilities and processes.
• Strong change management and influencing skills, with experience driving adoption of new approaches.
• Excellent conceptual, integrative, and communication skills; able to translate complex evidence into actionable insights for diverse audiences.
• Stakeholders/cross-functional engagement: works effectively across functions and geographies to deliver integrated evidence generation; experience in presenting RWE to Medical Affairs or cross-functional colleagues, as well as a science/clinical audience; ensures high-quality execution of RWE studies through CRO oversight.

Technical/Methodological Skills

• Proficiency in epidemiological study design (cohort, case-control, cross-sectional etc)
• Experience with causal inference methods (propensity score matching etc)
• Familiarity with database claims, EHR, patient registries
• Ability to develop and implement long-term RWE strategies aligned with organisational goals.
• Ability to critically appraise external RWE publications and vendor proposals/protocols
• Regulatory/scientific infrastructure: Familiarity with FDA and EMA guidance on RWD, RWE and related topics.
• Tools & analytics: Experience with data governance and privacy regulations (HIPAA, GPRD etc)

We would prefer for you to have

Experience in rare diseases or similar therapeutic areas is an advantage.

Location

The role can be based in one of Chiesi affiliates in Europe with an estimated 20% travel requirement, including international travel.