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

Ipsen•Cambridge, MA

12d

About The Position

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.

Requirements

At least 10 years of pharma experience in a related role
Significant industry experience (pharmaceutical, biotech, or CRO) applying psychometric principles to drug development programs.
Demonstrated track record of developing, validating, and/or implementing PRO instruments in clinical research.
Hands-on experience designing and conducting studies to establish MCID/clinically meaningful change.
Experience supporting regulatory, HTA, and payer-related evidence needs involving PRO data.
Strong methodological and analytical skills
Knowledge of medical, regulatory, and payor systems in one or more regions of the world
Demonstrated experience in designing and conducting PRO/psychometric studies in support of pre-/post-approval evidence generating activities
Expert in development, validation, implementation and interpretation of PRO instruments
Experience leading external analytic and evidence generating activities
Experience with conducting and designing studies around patient-reported outcomes
Excellent data analytic skills, including knowledge of standard statistical software (SAS, R, etc.)
Ability to translate complex psychometric concepts into clear, actionable guidance for diverse audiences.
Demonstrated ability to provide strong direct global project management/leadership skills
Exceptional critical thinking to help identify gaps, analyse findings and make recommendations while articulating next steps
Possession of core strategy and analysis skills, as well as the ability to lead and influence others by acting as a strategic partner to medical leaders
Skilled in applying emerging knowledge and trends, building strong relationships, and contributing to expertise within and beyond assigned area
Links responsibilities with the mission of the organisation; focusses on activities that add most value.
Advanced knowledge of psychometric methods, including classical test theory and modern measurement approaches.
Deep understanding of PRO endpoint strategy across clinical trials and real-world evidence.
Familiarity with regulatory guidance related to PROs and patient-focused drug development.
Fluent in English
Competent in medical terminology, specifically epidemiological terminology

Responsibilities

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 scientific publications.
Act as a scientific interface with regulatory agencies, HTA bodies, and external experts on PRO and psychometric-related topics.
Support interactions related to endpoint justification, instrument qualification, and interpretation of PRO results.
Represent Ipsen at scientific meetings, advisory boards, and external working groups.
Build and sustain Ipsen’s internal psychometrics and PRO capabilities through training, knowledge sharing, and cross-functional collaboration.
Mentor and guide team members and project colleagues on best practices in measurement science and patient-focused drug development.
Contribute to the development of internal SOPs, frameworks, and tools related to PRO and patient-centered evidence generation.
Provide budget input for activities related to studies and initiatives ensuring projects are adequately resourced.
Actively participate in review of study proposals, guidance and governance documents, and function-related standard operating procedures (SOPs).
Support in development of playbooks/guidance documents for activities built out as a part of the role/function.
Provides seamless and consistent support to global and local franchises.
Ensure linkage of insights gathered from external experts in close continuous partnership with key internal cross-functional partners.
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.