Title Director, Psychometrics & Patient-Reported Outcomes (PRO) Strategy About the Role 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. 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 with Clinical Development, Medical Affairs, Regulatory, Biostatistics, HEOR, and Patient Engagement to embed patient-centered outcomes consistently and strategically across Ipsen’s portfolio. Oversee and drive methodological strategy for patient-reported outcome studies, including instrument development, validation, and evaluation of clinically meaningful change (e.g., MCID). Collaborate with cross-functional teams to ensure well-designed patient-centered outcome endpoints are included in clinical development studies and regulatory submissions. Provide support for study design and planning activities and develop fit-for-purpose data generation and analytic methodologies across life-cycle stages. Develop and review study protocols and statistical analysis plans in collaboration with Biometrics, Medical and other internal stakeholders. Lead the design, adaptation, and validation of PRO instruments, including qualitative research, item generation, cognitive debriefing, and quantitative psychometric evaluation. Define clinically meaningful change using both 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. Act as the scientific interface with regulatory agencies, HTA bodies, and external experts on PRO and psychometric topics. 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 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 and support resource planning for PRO-related studies and initiatives. Collaborate with internal stakeholders to build capacity for psychometrics and PRO understanding across global and local franchises. Qualifications At least 10 years of pharma or related industry experience applying psychometric principles to drug development programs. Demonstrated track record of developing, validating, and implementing PRO instruments in clinical research. Hands‑on experience designing and conducting studies to establish MCID or clinically meaningful change. Experience supporting regulatory, HTA, and payer-related evidence needs involving PRO data. Strong methodological and analytical skills, including expertise in classical test theory and modern measurement approaches. Proficiency with standard statistical software (e.g., SAS, R). Ability to translate complex psychometric concepts into clear, actionable guidance for diverse audiences. Excellent data analytical skills and experience leading external analytic and evidence-generating activities. Strong project management and leadership skills, with the ability to influence and collaborate across disciplines. Exceptional critical thinking and problem-solving abilities. Knowledge of medical, regulatory, and payer systems in one or more regions of the world. Experience building relationships and influencing stakeholders as a strategic partner to medical leaders. Education / Certifications PhD or equivalent doctoral degree in Psychometrics, Psychology, Biostatistics, Health Outcomes Research, Measurement Science, or a closely related quantitative discipline. Languages Fluent in English. Competent in medical terminology, specifically epidemiological terminology. Salary and Benefits Annual base salary range: $177,000 to $259,600. The position is eligible for short-term and long-term incentive programs. 401(k) with company contributions Group medical, dental, and vision coverage Life and disability insurance Short- and long-term disability insurance Flexible spending accounts Parental leave and paid time off Well-being allowance and commuter benefits Equal Opportunity Employment 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. Disclaimer This description is not intended to be an exhaustive list of duties, responsibilities, or requirements. The position may change or assume additional duties; employees may be asked to perform different or additional duties as assigned. All employees are expected to adhere to company policies and act as role models for the company’s values. #J-18808-Ljbffr
Director, Psychometrics & Patient-Reported Outcomes (Pro) Strategy
IPSEN BIOPHARMACEUTICALS INC.
cambridge, cambridge
Published 4 days ago
Report job