The posting
Who we are ?
We are Pierre Fabre Laboratories, a global leader combining pharmaceutical expertise with dermo-cosmetics to support consumers and patients at every stage of their care journey. Our portfolio includes several medical franchises and international brands such as Eau Thermale Avène, Ducray, A-Derma, Klorane, René Furterer, and Pierre Fabre Oral Care. By joining us, you become part of a meaningful company where the human dimension is essential. You become a participant in the "We Care Movement," a movement that values excellence and innovation within passionate teams. Together, we push the boundaries of science to unite health and beauty for the benefit of all, because Every time we care for a single person, we make the whole world better.
Present in 120 countries with a team of over 10,000 employees, we are proud to create a scientific and human impact, today and tomorrow! If caring is at the heart of your values, join Pierre Fabre Laboratories and become a key player in the “We Care Movement".
Your mission
The Integrated RWE Strategy department, part of the Medical & Patient Consumer Division, is seeking a Real World Evidence Strategy Lead, based at its Boulogne or Toulouse site. You will be responsible for the scientific strategy of real-world evidence generation projects, ensuring their alignment with medical, regulatory and strategic objectives. You will lead the methodological design of RWE studies and be accountable for the rigorous and critical interpretation of data, in order to deliver robust conclusions and clear, actionable messages.
Your role within the Integrated RWE Strategy department
- Define and drive the scientific strategy for real-world evidence (RWE) generation for assigned products, indications or programs, in alignment with medical, regulatory and public health priorities. Contribute, together with R&D, Medical Affairs, HEOR, Regulatory, Biometry and other departments, to the Integrated Evidence Generation Plan (IEGP), ensuring the consistency and strategic value of the evidence generated.
- Challenge and refine the scientific, medical and regulatory objectives of projects, and translate decision-making questions into relevant research questions.
- Lead the methodological design of RWE studies, from the formulation of the research question through to the final design: population, exposure/intervention, comparator, endpoints, study period, strategy for controlling bias and confounding, sensitivity analyses and statistical approaches, in close collaboration with biostatisticians.
- Identify and select the most relevant and usable data sources for each research question. Conduct or oversee Fit-for-Purpose Assessments (FFPA) to document, in a structured manner, the suitability of one or more data sources for a given research question.
- Develop in-depth expertise in the assigned diseases and indications, standards of care, available data sources, RWE methods and regulatory expectations, in order to justify and defend methodological choices throughout study development.
- Be accountable for the scientific rigour of protocols and oversee the development of statistical analysis plans. Anticipate biases, confounding factors, missing data and methodological limitations, and define appropriate mitigation strategies.
- Critically interpret the results of complex analyses and place them in their clinical, methodological and regulatory context. Turn results into scientifically robust conclusions and recommendations that support decision-making. Disseminate these results through reports, abstracts, posters, publications and other scientific materials.
- Provide scientific support to operational teams and external partners to ensure implementation that is faithful to the protocol, the scientific objectives and the methodological requirements of the study.
- Review and scientifically validate RWE studies initiated by affiliates and contribute to building team capabilities by promoting good practices in pharmacoepidemiology and RWE.
Who you are ?
- Education: Master's degree or PhD in epidemiology, pharmacoepidemiology or public health, or medical doctor/pharmacist with significant experience in designing observational studies.
- Strong analytical and methodological skills, with a demonstrated ability to design studies, apply advanced pharmaco-epidemiological approaches, and interpret and communicate complex analyses.
- Proven experience as Lead Author of observational study protocols: direct and full responsibility for the methodological design of the study and the development of the protocol. Experience focused primarily on project management or study operations does not meet the requirements of the position.
- Demonstrated experience in the design and/or scientific conduct of comparative and/or regulatory-grade observational studies, particularly for the EMA or FDA.
- Demonstrated experience in the design and implementation of IEGPs.
- Hands-on experience with different categories of real-world data – claims/administrative healthcare data, EHR/EMR and/or disease-specific registries – particularly from the United States, Europe or Asia.
- In-depth understanding of the differences between these data sources, how they are built and collected, and the ability to conduct or oversee Fit-for-Purpose Assessments (FFPA) and to make a well-argued recommendation on study feasibility and the choice of data source(s).
- Command of pharmacoepidemiology principles and good practices, as well as advanced methodological approaches.
- Ability to work with multidisciplinary profiles (clinicians, Medical Affairs, Regulatory, Safety/PV, HEOR, biostatisticians, data scientists and operational teams).
- Fluent spoken and written English.
Key differentiating criteria for the position
The position first and foremost requires a scientific profile capable of taking scientific and methodological ownership of an RWE study. The expected seniority must be evidenced by concrete achievements.
At Pierre Fabre Laboratories, we believe that our greatest asset is our people.
We are committed to a policy of Equal Employment Opportunity and will not discriminate against an applicant or employee based on race, color, religion, creed, national origin or ancestry, sex, sexual orientation, gender identity or expression, age, physical or mental disability, veteran or military status, genetic information, or any other legally recognized protected basis under federal, state, or local law. The information collected by this application is solely to determine suitability for employment, verify identify, and maintain employment statistics on applicants. Applicants with disabilities may be entitled to reasonable accommodation under the Americans with Disabilities Act and certain state or local laws. Please inform the company’s personnel representative if you need assistance completing this application or to otherwise participate in the application process. Thus, we commit to considering all applications equally, without fail.
