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

Company:
Ipsen Biopharmaceuticals Inc.

About Ipsen:

Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Supported by nearly 100 years of development experience, with global hubs in the U.S., France and the U.K, we tackle areas of high unmet medical need through research and innovation.

Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries. We build a workplace that champions human-centric leadership and fosters a culture of collaboration, excellence and impact. At Ipsen, every individual is empowered to be their true selves, grow and thrive alongside the company's success. Join us on our journey towards sustainable growth, creating real impact on patients and society!

For more information, visit us at https://www.ipsen.com/ and follow our latest news on LinkedIn and Instagram.

Job Description:

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.

PRO Strategy & Psychometrics Leadership

• 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.

PRO Instrument Development & Validation

• 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.

Study Design & Evidence Generation

• 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.

Regulatory & External Engagement

• 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.

Capability Building & Mentorship

• 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.

Administrative

• 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.

Collaborate with Internal Stakeholders on Building Capacity for Psychometrics and PRO Understanding

• 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.

Knowledge & Experience (preferred):

• 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.

Technical Expertise

• 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.

Education / Certifications (essential):

• PhD or equivalent doctoral degree in Psychometrics, Psychology, Biostatistics, Health Outcomes Research, Measurement Science, or a closely related quantitative discipline

Language(s) (essential):

• Fluent in English
• Competent in medical terminology, specifically epidemiological terminology

Ipsen Biopharmaceuticals, Inc. is an equal opportunity employer. We recruit, employ, train, compensate, and promote without regard to race, religion, creed, national origin, age, gender, sexual orientation, sexual identity, marital status, military or veteran status, disability, genetic information, or any other category protected by applicable federal, state or local law.

Ipsen Biopharmaceuticals, Inc. conducts background screening, reference checks, and drug testing as part of its pre-employment screening process. This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time. The employee may be requested to perform different or additional duties as assigned.

All Employees are expected to adhere to all company policies and act as a role model for company values.

The annual base salary range for this position is $177,000-$259,600.

This job is eligible to participate in our short-term incentives program as well as our long-term incentives program.

At Ipsen we are proud to offer a comprehensive employee benefits package, including 401(k) with company contributions, group medical, dental and vision coverage, life and disability insurance, short- and long-term disability insurance, as well as flexible spending accounts. Ipsen also provides parental leave, paid time off, a discretionary winter shutdown, well-being allowance, commuter benefits, and much more.

The pay range displayed above is the range of base pay compensation within which Ipsen expects to pay for this role at the time of this posting. Individual compensation within this range depends on a variety of factors, including, but not limited to, prior education and experience, job-related knowledge and demonstrated skills

We are committed to creating a workplace where everyone feels heard, valued, and supported; where we embrace "The Real Us". The value we place on different perspectives and experiences drives our commitment to inclusion and equal opportunities. When we include diverse ways of thinking, we make more thoughtful decisions and discover more innovative solutions. Together we strive to better understand the communities we serve. This means we also want to help you perform at your best when applying for a role with us. If you require any adjustments or support during the application process, please let the recruitment team know. This information will be handled with care and will not affect the outcome of your application. Ipsen is an equal opportunity employer that strictly prohibits unlawful discrimination. We recruit, employ, train, compensate, and promote without regard to an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.