Director, Psychometrics & Patient-Reported Outcomes; PRO) Strategy

The Director, Psychometrics & Patient-Reported Outcomes (PRO) Strategy is a senior scientific leadership role responsible for defining and advancing Ipsen’s enterprise wide PRO strategy across the full product life cycle. This role provides psychometric and methodological leadership to ensure that patient-reported outcome evidence generated by Ipsen is scientifically rigorous, fit-for-purpose, and aligned with regulatory, payer, and health technology assessment (HTA) expectations.

The position will lead the design, development, validation, and interpretation of PRO instruments, including both bespoke and existing measures, and will oversee studies to establish measurement properties and clinically meaningful change (e.g., MCID/meaningful within-patient change). The role partners cross functionally with Clinical Development, Medical Affairs, Regulatory, Biostatistics, HEOR, and Patient Engagement to ensure patient-centered outcomes are embedded consistently and strategically across Ipsen’s portfolio.

• Define and lead Ipsen’s global PRO and psychometrics strategy across early development, registrational programs, post-approval evidence generation, and life‑cycle management.
• Serve as the internal subject matter expert for psychometrics, PRO measurement science, and endpoint strategy.
• Establish standards, best practices, and governance for PRO selection, development, validation, and use across therapeutic areas.
• Partner effectively across the enterprise to support the identified psychometric needs across Oncology, Rare Disease and Neuroscience and play a central role in designing PRO strategies that address key evidence needs and gaps;
• Oversee and drive methodologic strategy for patient-reported/patient-centered outcome study strategies & designs, including studies where patient-reported outcome (PRO) instruments are to be developed and/or validated and/or evaluations need to be conducted around mapping of clinically meaningful changes in patient-reported outcome measurements;
• Collaborate with cross-functional teams to ensure well designed patient-centered outcome endpoints are included in clinical development studies and patient-centric endpoints are available for HTA and regulatory submissions;
• Partner with Clinical Development teams to provide support for study design and planning activities;
• Support, as relevant, design of fit-for-purpose data generation and analytic methodologies that advance research goals across different LCM stages;
• Develop and review study protocols and statistical analyses plans in collaboration with Biometrics, Medical and other internal stakeholders;
• Stay informed and involved on the latest HTA and Regulatory and methodological advances that expand and enhance the utility of PROs.

• Lead or oversee the development, adaptation, and validation of PRO instruments, including qualitative research, item generation, cognitive debriefing, and quantitative psychometric evaluation.
• Design and interpret psychometric analyses, including reliability, validity, responsiveness, and longitudinal performance.
• Lead methodologies to define clinically meaningful change, including MCID/MWPC, responder definition, and anchor‑and distribution‑based approaches.

• Provide strategic input into clinical trial and observational study design to ensure appropriate PRO endpoints, assessment schedules, and statistical considerations.
• Partner with Epidemiology, RWE, and Biostatistics to integrate PROs into interventional trials, real‑world studies, registries, and external collaborations.
• Ensure PRO evidence supports regulatory submissions, labeling claims (where appropriate), value dossiers, and…