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Director, Epidemiology & RWE Sciences – Ipsen Biopharmaceuticals Inc.

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, ensuring 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.

Responsibilities

• Evidence Strategy and Leadership: Partner effectively across the enterprise to support 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 and disease area priorities.
• Provide strategic input to shape evidence that addresses regulatory, HTA, payer, clinician, and patient needs across the product lifecycle.
• 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 cross‑functional partners to ensure scientific robustness and alignment with strategic goals.
• Ensure 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 epidemiology 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 staff and other internal stakeholders.
• Stay informed 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 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 modelling.
• 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 (advanced statistical modelling, real‑world data enrichment, linkage of disparate data sources, 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 using 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.
• Establish end‑to‑end best practices for data generation and sharing (policy, SOP, legal, privacy, etc.).

Required Knowledge & Experience

• 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 in pharmaco‑epidemiology studies.
• Knowledge of medical, regulatory, and payer systems in one or more regions of the world.
• Demonstrated experience in designing and conducting pharmaco‑epidemiology studies to support pre‑/post‑approval evidence generation.
• Expertise applying innovative methodologies and modern analytic approaches to RWE, ideally in oncology 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.).
• Strong project management and leadership skills, able to manage global teams.
• Exceptional critical thinking, ability to identify gaps, analyse findings and make recommendations.
• Ability to collaborate in a matrix and remote organizations.
• Strong communication, presentation and influencing skills.
• Ability to prioritize effectively and work independently as well as in cross‑functional teams.
• Experience in innovative design thinking and cross‑cultural awareness.

Education / Certifications

• 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

• Fluent in English.

Additional Information

Annual base salary range: $177,000–$259,600. Eligibility for short‑term and long‑term incentive programs. Comprehensive employee benefits package includes 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, discretionary winter shutdown, well‑being allowance, commuter benefits, and more.

Equal Opportunity Employer

Ipsen Biopharmaceuticals, Inc. is an equal opportunity employer. We recruit, employ, train, compensate, and promote without regard to race, religion, creed, national origin, age, gender, sexual orientation, sexual identity, marital status, military status, disability, genetic information, or any other category protected by applicable federal, state, or local law. Ipsen conducts background screening, reference checks, and drug testing as part of its pre‑employment screening process. If you require adjustments or support during the application process, please let the recruitment team know. This information will be handled with care and will not affect the outcome of your application.

Applications are currently open. The position may change or assume additional duties at any time. All employees are expected to adhere to all company policies and act as a role model for company values.