Director, Epidemiology & RWE Sciences

Director, Epidemiology & RWE Sciences

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!

The Director, Epidemiology and RWE Sciences will support pre- and post-launch evidence generating activities across all Oncology products. The role is responsible for leading the global evidence strategy and real-world evidence generation for Ipsen's oncology assets across the product lifecycle. This role provides 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.

The Director will define and execute integrated evidence plans (IEPs), oversee RWE studies (e.g., registries, retrospective and prospective observational studies, database studies), and partner closely with Global Medical Affairs, Clinical Development, Regulatory Affairs, Market Access, HEOR, Biostatistics, and Safety.

The role will 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. The Director will also take a lead in serving as a subject matter expert and in building capacity for RWE research across the business. The role operates in a global, matrixed environment and ensures evidence generation adheres to scientific, regulatory, and compliance standards.

Main Responsibilities & Technical Competencies

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, ensuring alignment with product strategy, disease area priorities, and Ipsen's broader evidence generation objectives.
• 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.
• Develop and review study protocols and statistical analysis plans in collaboration with Biometry, Medical and other internal stakeholders.
• Stay informed and involved on the latest regulatory and methodological advances that expand and enhance the utility of RWE.
• Educate and raise the awareness around epidemiologic methods and RWE and its potential in supporting Ipsen's internal teams to generate buy-in across the organization
• Mentor and provide functional leadership to RWE and evidence generation team members as applicable.

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…