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About the Role
The Director, Epidemiology and RWE Sciences will support pre- and post-launch evidence generating activities across all Oncology products. You will define and execute integrated evidence plans (IEPs), oversee RWE studies and partner closely with Global Medical Affairs, Clinical Development, Regulatory Affairs, Market Access, HEOR, Biostatistics, and Safety. The role operates in a global, matrixed environment and ensures evidence generation adheres to scientific, regulatory, and compliance standards.
Responsibilities
- Provide methodological epidemiological & RWE leadership and contribute to the development of new SOPs and guidance documents.
- Serve as a subject matter expert and build capacity for RWE research across the business.
- Lead the global evidence strategy and real-world evidence generation for Ipsen’s oncology assets across the product lifecycle.
- Provide scientific and strategic leadership to ensure robust, fit-for-purpose RWE is generated to support decision-making.
- Partner across the enterprise to support evidence needs in Oncology and design Integrated Evidence Generation Plans (IEGPs).
- Provide strategic input to shape evidence addressing regulatory, HTA, payer, clinician, and patient needs.
- Drive the RWE strategy per asset as part of IEGPs in partnership with Asset Teams.
- Conduct critical review of RWE/Epidemiology studies designed by external service providers and/or cross-functional partners.
- Ensure timely, high-quality epidemiology/RWE sections of Regulatory documents for agencies worldwide.
- Support External Innovation and Business Development teams by providing timely disease population assessments.
- Partner with Clinical Development teams to provide Epi support for study design and planning.
- Engage externally with academic collaborators, patient registries, data partners, and methodological experts.
- Design prospective and retrospective pharmaco-epidemiology studies (including RWE studies) in the pre-/post-launch setting.
- Develop and adopt robust, fit-for-purpose data generation and analytic methodologies.
- Drive the adoption of modern RWE methodologies and analytic techniques.
- Apply and champion innovative study designs and modern analytics.
- Oversee vendor-led and internally led RWE studies, including protocol development, study governance, timelines, quality, and budgets.
- Ensure methodological rigor while balancing scientific innovation, feasibility, and regulatory acceptability.
- Leverage contemporary data analytic methods to generate novel insights.
- Partner with Biostatistics, Data Science, and external vendors to ensure appropriate application and interpretation of advanced analytics.
- Provide budget input for Epidemiology and RWE studies and initiatives.
- Ensure all RWE activities comply with internal SOPs, global regulations, data privacy requirements, and ethical standards.
- Actively participate in review of study proposals.
- Provide seamless and consistent support to global and local franchises.
- Ensure linkage of study data and insights gathered from external experts.
- Involve Ipsen stakeholders in the design and implementation of the RWE framework.
- Ensure Ipsen can provide comprehensive patient-focused data & analytics.
- Drive Medical, cross-functional and global alignment for early strategic alignment of Medical Affairs.
- Ensure late phase data generation plans maximize data availability, patient impact and effective execution of RWE programs.
- Establish end-to-end best practices for data generation and sharing.
Requirements
- PhD or equivalent doctoral degree in Psychometrics, Psychology, Biostatistics, Health Outcomes Research, Measurement Science, or a closely related quantitative discipline.
- Extensive 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.).
- Exceptional critical thinking to help identify gaps, analyze findings and make recommendations while articulating next steps.
- 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.
Skills
- Epidemiology
- Real-World Evidence (RWE)
- Integrated Evidence Plans (IEPs)
- Psychometric principles
- PRO instruments
- MCID/clinically meaningful change
- Regulatory evidence needs
- HTA evidence needs
- Payer evidence needs
- Methodological skills
- Analytical skills
- Medical systems knowledge
- Regulatory systems knowledge
- Payor systems knowledge
- PRO/psychometric studies
- PRO instrument development
- PRO instrument validation
- PRO instrument implementation
- PRO instrument interpretation
- External analytic activities
- External evidence generating activities
- Patient-reported outcomes studies
- Data analytic skills
- SAS
- R
- Critical thinking
- Psychometric methods
- Classical test theory
- Modern measurement approaches
- PRO endpoint strategy
- Clinical trials
- Real-world evidence
- Regulatory guidance related to PROs
- Patient-focused drug development
Location
- Global
Work Type
- Hybrid
Experience Level
- Director
- Extensive years of pharma experience
- Significant industry experience
Education Level
- PhD or equivalent doctoral degree in Psychometrics, Psychology, Biostatistics, Health Outcomes Research, Measurement Science, or a closely related quantitative discipline.
About the Company
- 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!
- Ipsen is a growing global specialty-driven biopharmaceutical company focused on innovation and specialty care.
- We aim to make a sustainable difference by significantly improving patients’ health and quality of life, providing effective therapeutic solutions for unmet medical needs through differentiated and innovative medicines in Oncology, Neurosciences, and Rare Diseases.
- Patient-Focused: The patient is at the heart of everything we do, and improving their outcomes is the deliverable of every strategy.
- Employee Care: We care for our employees, who are the ambassadors making a real difference.
- Bold Leadership: We attract and develop bold, agile, entrepreneurial individuals who take full ownership of their decisions.
- Growth Opportunities: We offer a wealth of fulfilling challenges and growth opportunities in a fast-moving, game-changing organization.
Equal Opportunity
- Nous nous engageons à créer un lieu de travail où chacun se sent écouté, valorisé et soutenu, où nous incarnons « The Real Us*». La valeur que nous accordons aux différentes perspectives et expériences motive notre engagement en faveur de l'inclusion et de l'égalité des chances. Lorsque nous intégrons des modes de pensée diversifiés, nous prenons des décisions plus réfléchies et découvrons des solutions plus innovantes. Ensemble, nous nous efforçons de mieux comprendre les communautés que nous servons. Cela signifie que nous voulons également vous aider à donner le meilleur de vous-même lorsque vous postulez à un poste chez nous. Si vous avez besoin d'aménagements ou d'aide pendant le processus de candidature, veuillez en informer l'équipe de recrutement. Ces informations seront traitées avec soin et n'auront aucune incidence sur le résultat de votre candidature. *Soyons nous-même