Director Epidemiology & RWE Sciences

About the role

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.

Responsibilities

• Support pre- and post-launch evidence generating activities across various Rare Disease products.
• Lead the global evidence strategy and real world evidence generation for Ipsen’s rare disease 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 rare and ultra rare indications.
• 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.
• Contribute to the development of new SOPs and guidance documents that will promote and ensure timely and high-quality, “fit-for-purpose” evidence generation.
• Serve as a subject matter expert and build capacity for RWE research across the business.
• Ensure evidence generation adheres to scientific, regulatory, and compliance standards.
• Partner with External Innovation and Business Development teams in assessing external licensing opportunities by providing timely disease population assessments.
• Support study design and planning activities with Clinical Development teams.
• 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.
• Design and conduct prospective and retrospective pharmaco-epidemiology studies (including RWE studies) in the pre-/post-launch setting, including related to Regulatory post-approval commitments.
• 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.
• 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.
• Participate in review of study proposals.
• Provide seamless and consistent support to global and local franchises.
• Establish end-to-end best practices for data generation and sharing (policy, SOP, Legal, Privacy, etc.).

Qualifications

• 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.
• 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.

Skills

• Advanced degree in Epidemiology, Public Health, Health Outcomes Research, Pharmacoepidemiology, Biostatistics, Medicine (MD), or a related scientific discipline.
• PhD or MD/MPH strongly preferred.
• Fluent in English.

Benefits

At Ipsen, we offer a comprehensive employee benefits package, including:

• 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
• Flexible time off
• Winter shutdown
• Well-being allowance
• Commuter benefits
• and much more.

Pay

The annual base salary range for this position is $177,000-$259,600. This job is eligible to participate in our short-term incentives program as well as our long-term incentives program.

Schedule

This position operates in a global, matrixed environment.