Director, Epidemiology & RWE Sciences

Director, Epidemiology & RWE Sciences – Ipsen Biopharmaceuticals Inc.

The Director, Epidemiology and RWE Sciences will support pre‑ and post‑launch evidence generating activities across all Oncology products. The role is responsible for leading the global evidence strategy and real‑world evidence generation for Ipsen’s oncology assets across the product lifecycle, ensuring robust, fit‑for‑purpose RWE is generated to support regulatory, payer, clinical, and medical decision‑making, with a strong focus on high‑unmet‑need oncology indications.

• Evidence Strategy and Leadership
  :
  Partner effectively across the enterprise to support identified evidence needs across Oncology and play a central role in designing Integrated Evidence Generation Plans (IEGPs) that address evidence gaps and contribute to the global Integrated Data and Evidence vision at Ipsen, ensuring alignment with product strategy and disease area priorities.
• Provide strategic input to shape evidence that addresses regulatory, HTA, payer, clinician, and patient needs across the product lifecycle.
• In partnership with the Asset Teams, drive the RWE strategy per asset as part of IEGPs.
• Conduct critical review of RWE/Epidemiology studies designed by external service providers and cross‑functional partners to ensure scientific robustness and alignment with strategic goals.
• Ensure timely, high‑quality epidemiology/RWE sections of regulatory documents for agencies worldwide, including submissions, RMPs, breakthrough or orphan designations, advisory committee briefing books, etc.
• Support External Innovation and Business Development teams in assessment of external licensing opportunities by providing timely disease population assessments.
• Partner with Clinical Development teams to provide epidemiology support for study design and planning activities.
• Engage externally with academic collaborators, patient registries, data partners, and methodological experts to advance Ipsen’s evidence capabilities and scientific reputation.
• Develop and review study protocols and statistical analysis plans in collaboration with biometry, medical staff and other internal stakeholders.
• Stay informed on the latest regulatory and methodological advances that expand and enhance the utility of RWE.
• Educate and raise the awareness around epidemiologic methods and RWE and its potential in supporting Ipsen’s internal teams to generate buy‑in across the organization.
• Mentor and provide functional leadership to RWE and evidence generation team members as applicable.
• Real‑World Evidence Generation
  :
  Design prospective and retrospective pharmaco‑epidemiology studies (including RWE studies) in the pre‑/post‑launch setting, including regulatory post‑approval commitments.
• Develop and adopt robust, fit‑for‑purpose data generation and analytic methodologies that advance research goals across different life‑cycle management stages.
• Drive the adoption of modern RWE methodologies and analytic techniques to generate impactful evidence in settings where conventional approaches may be limited.
• Apply and champion innovative study designs and modern analytics, such as pragmatic approaches, hybrid designs, external control arms, advanced causal inference methods, and longitudinal disease modelling.
• Oversee vendor‑led and internally led RWE studies, including protocol development, study governance, timelines, quality, and budgets.
• Ensure methodological rigor while balancing scientific innovation, feasibility, and regulatory acceptability in oncological or rare disease contexts.
• Leverage contemporary data analytic methods (advanced statistical modelling, real‑world data enrichment, linkage of disparate data sources, exploratory use of machine‑learning‑enabled approaches where appropriate) to generate novel insights.
• Partner with biostatistics, data science, and external vendors to ensure appropriate application and interpretation of advanced analytics within RWE studies.
• Administration
  :
  Provide budget input for activities related to epidemiology and RWE studies and initiatives ensuring projects are adequately resourced.
• Ensure all RWE activities comply with internal SOPs, global regulations,…