Title:Director Epidemiology & RWE Sciences
Company:Ipsen Biopharmaceuticals Inc.
Job Description:The Director, Epidemiology and RWE Sciences will support pre- and post-launch evidence generating activities across various Rare Disease products. The role is responsible for leading the global evidence strategy and real world evidence generation for Ipsen's rare disease 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 rare and ultra rare 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.
Evidence Strategy and Leadership:- Partner effectively across the enterprise to support the identified evidence needs across Rare Diseases 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 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 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 (GMA TAs, HEOR, GMA Clin Ops, GMPC, R&D and affiliates) 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 (policy, SOP, Legal, Privacy, etc.).
HOW - Knowledge & ExperienceKnowledge & Experience (essential):
- Minimum 8-10 years of biotech/pharmaceutical experience in an Epidemiology, clinical RWE or outcomes research role within the pharmaceutical, biotech, or healthcare research environment
- 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 pharmaco-epidemiology studies in support of pre-/post-approval evidence generating activities
- Demonstrated experience applying innovative methodologies and modern analytic approaches to RWE, ideally in rare or specialty diseases
- Expert in data collection methods and strong familiarity with secondary data sources
- Experience leading external analytic and evidence generating activities
- Excellent data analytic skills, including knowledge of standard statistical software & packages (SAS, R, etc.)
- 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
- Applies emerging knowledge and trends; builds strong relationships; contributes to expertise within and beyond assigned area
- Links responsibilities with the mission of the organisation; focusses on activities that add most value
- Demonstrated ability to collaborate in a matrix and remote organizations
- Ability to work, lead and thrive in a cross-functional team environment
- Ability to work independently and as an active member within cross-functional teams
- Demonstrated experience in innovative and design thinking
- Cross-cultural awareness
- Excellent verbal communication, written, interpersonal, presentation and influencing skills
- Ability to prioritize effectively
Education / Certifications (essential):
- Advanced degree in Epidemiology, Public Health, Health Outcomes Research, Pharmacoepidemiology, Biostatistics, Medicine (MD), or a related scientific discipline required.
- PhD or MD/MPH strongly preferred.
Language(s) (essential):
