Cambridge, MA30+ days ago
li>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. - Fully involve Ipsen stakeholders (GMA TAs, R&D, HEOR, Regulatory, Clin Ops, GMPC, and affiliates) in the design and implementation of studies around PROs, from design to communication;
- Ensure Ipsen can provide comprehensive patient focused data & analytics in the disease areas we serve;
- Drive cross-functional and global dialogue to enable early strategic alignment of PRO data across global and local teams, in partnership with the cross-functional partners across product life cycles, to ensure company is working with single source of information;
- Establish end-to-end best practice for information sharing regarding PROs used across assets;
- Conduct educational sessions around key topics of interest and relevance to internal stakeholders, with a goal to build educational modules.