Director, Epidemiology & RWE Sciences

Title

Director, Epidemiology & RWE Sciences

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.

Are you ready to lead and innovate in a dynamic, patient-focused biopharmaceutical company?

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.

Why Ipsen?

• 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.

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.

Main Responsibilities

• Be responsible for methodological epidemiological & RWE leadership and will contribute the development of new SOPs and guidance documents that will promote and ensure timely and high-quality, “fit-for-purpose” evidence generation.
• Take a lead in serving as a subject matter expert and in building capacity for RWE research across the business.
• Responsible for leading 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 that robust, fit‑for‑purpose RWE is generated to support regulatory, payer, clinical, and medical decision‑making, with a strong focus on high‑unmet‑need oncology indications.

Evidence Strategy and Leadership

• Partner effectively across the enterprise to support the identified evidence needs across Oncology and play a central role in designing Integrated Evidence Generation Plans (IEGPs) that address evidence gaps and contribute to the global Integrated Data and Evidence vision at Ipsen
• Provide strategic input to shape evidence that addresses regulatory, HTA, payer, clinician, and patient needs.
• In partnership with the Asset Teams, drive the RWE strategy per asset as part of IEGPs
• Conduct critical review of RWE/Epidemiology studies designed by external service providers and/or cross-functional partners to ensure scientific robustness and alignment with strategic goals.
• Ensure the fulfilment of timely, high-quality epidemiology/RWE sections of Regulatory documents for agencies worldwide, including submissions, RMPs, breakthrough or orphan designations, advisory committee briefing books, etc.
• Support External Innovation and Business Development teams in assessment of external licensing opportunities by providing timely disease population assessments.
• Partner with Clinical Development teams to provide Epi support for study design and planning activities.
• Engage externally with academic collaborators, patient registries, data partners, and methodological experts to advance Ipsen’s evidence capabilities and scientific reputation.

Real-World Evidence Generation

• Design prospective and retrospective pharmaco-epidemiology studies (including RWE studies) in the pre-/post-launch setting, including related to Regulatory post-approval commitments.
• Develop and adopt robust, fit-for-purpose data generation and analytic methodologies that advance research goals across different life cycle management stages.
• Drive the adoption of modern RWE methodologies and analytic techniques to generate impactful evidence in settings where conventional approaches may be limited.
• Apply and champion innovative study designs and modern analytics, such as pragmatic approaches, hybrid designs, external control arms, advanced causal inference methods, and longitudinal disease modeling, as appropriate.
• 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 in oncological or rare disease contexts.
• Leverage contemporary data analytic methods (e.g., advanced statistical modeling, real‑world data enrichment, linkage of disparate data sources, and exploratory use of machine‑learning–enabled approaches where appropriate) to generate novel insights.
• Partner with Biostatistics, Data Science, and external vendors to ensure appropriate application and interpretation of advanced analytics within RWE studies.

Administration

• Provide budget input for activities related to Epidemiology and RWE studies and initiatives ensuring projects are adequately resourced.
• 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, including HCPs and patient organisations, in close continuous partnership with Medical Asset Leads and Therapy Areas.

Collaborate with internal Ipsen stakeholders on all topics around RWE:

• Fully involve Ipsen stakeholders in the design and implementation of the RWE framework utilizing strong communication skills.
• Ensure Ipsen can provide comprehensive patient focussed data & analytics in the disease areas we serve.
• Drive Medical, cross-functional and global alignment to enable early strategic alignment of Medical Affairs.
• Epidemiology and RWE studies across global and local teams, in partnership with the Medical Asset Leads, to ensure late phase data generation plans maximise data availability, ensure patient impact and effective execution of RWE programs.
• Establish end-to-end best practices for data generation and sharing

Qualifications

• 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, and 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

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