Director Epidemiology & RWE Sciences

Director Epidemiology & RWE Sciences Position at Ipsen Biopharmaceuticals Inc. The role supports pre‑ and post‑launch evidence generation activities across various Rare Disease products, leading the global evidence strategy and real‑world evidence generation for Ipsen’s rare disease assets across the product lifecycle. Job Summary The Director provides scientific and strategic leadership to ensure 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. Key Responsibilities Define and execute Integrated Evidence Plans (IEPs), oversee RWE studies (registries, retrospective and prospective observational studies, database studies), and partner closely with cross‑functional teams. Contribute to the development of new SOPs and guidance documents that promote timely, high‑quality evidence generation. Act as subject‑matter expert and build RWE research capacity across the business. Ensure evidence generation adheres to scientific, regulatory, and compliance standards in a global matrixed environment. Partner across the enterprise to design Integrated Evidence Generation Plans (IEGPs), addressing evidence gaps and aligning with product strategy and disease area priorities. Conduct critical review of RWE/Epidemiology studies, ensuring scientific robustness and alignment with strategic goals. Ensure timely, high‑quality epidemiology/RWE sections of regulatory documents worldwide. Support external innovation and business development teams in assessing external licensing opportunities by providing disease population assessments. Partner with Clinical Development teams to support study design and planning. Engage externally with academic collaborators, patient registries, data partners, and methodological experts. Develop study protocols and statistical analysis plans in collaboration with Biometry, Medical and other stakeholders. Educate and raise awareness of epidemiologic methods and RWE across the organization. Provide functional leadership to RWE and evidence generation team members. Design prospective and retrospective pharmaco‑epidemiology studies, including RWE studies in pre‑/post‑launch settings. Drive adoption of modern RWE methodologies and analytic techniques to generate impactful evidence. Oversee vendor‑led and internally led RWE studies, including protocol development, governance, timelines, quality, and budgets. Leverage contemporary data analytic methods, including advanced statistical modeling and machine‑learning when appropriate. Assist in budget planning for Epidemiology and RWE initiatives, ensuring projects are resourced. Ensure all RWE activities comply with SOPs, regulations, data privacy, and ethical standards. Participate actively in study proposal reviews and support global and local franchises. Catalyze cross‑functional alignment to enable early strategic alignment of Medical Affairs. Knowledge & Experience (Essential) 8‑10 years of experience in Epidemiology, clinical RWE, or outcomes research within pharma, biotech, or healthcare research. Strong methodological and analytical skills. Knowledge of medical, regulatory, and payer systems in one or more regions. Experience designing and conducting pharmaco‑epidemiology studies for pre‑/post‑approval evidence generation. Experience applying innovative methodologies and modern analytic approaches to RWE, especially in rare or specialty diseases. Expertise in data collection methods and secondary data sources. Experience leading external analytic and evidence generation activities. Excellent data analytic skills, including SAS, R, etc. Strong global project management and leadership skills. Exceptional critical thinking and communication skills. Ability to collaborate in matrix and remote organizations. Cross‑cultural awareness and strong presentation skills. Education / Certifications (Essential) Advanced degree in Epidemiology, Public Health, Health Outcomes Research, Pharmacoepidemiology, Biostatistics, Medicine (MD), or related discipline required. PhD or MD/MPH strongly preferred. Language(s) (Essential) Fluent in English. Equal Opportunity Statement 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 or veteran status, disability, genetic information, or any other category protected by applicable law. Compensation and Benefits Annual base salary range: $177,000 – $259,600. Eligible for short‑term and long‑term incentive programs. Benefits include 401(k) with company contributions, group medical, dental and vision coverage, life and disability insurance, short‑and long‑term disability, flexible spending accounts, parental leave, paid time off, winter shutdown, well‑being allowance, commuter benefits, and more. #J-18808-Ljbffr Ipsen Biopharmaceuticals Inc.