Director, Epidemiology, RWE Sciences

Ipsen

. Support pre- and post-launch evidence-generating activities across Oncology products .

Posted 10/23/2026full-timeParis • FranceLeadWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Real-World Evidence (RWE) generation and psychometric principles, with a strong focus on developing and validating Patient-Reported Outcomes (PRO) instruments. Proven ability to lead cross-functional teams and drive evidence strategies that meet regulatory and payer needs.

Highest-signal resume keywords

PhD In PsychometricsReal-World Evidence GenerationPatient-Reported Outcomes ExpertiseStatistical Software Proficiency (SAS, R)Regulatory Affairs Knowledge

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

EpidemiologyAnalytical MethodologiesStudy DesignData AnalysisPsychometric MethodsEvidence GenerationClinical ResearchStatistical ModelingData LinkageAdvanced Causal Inference

Soft Skills

Critical ThinkingCollaborationLeadershipCommunicationStrategic Thinking

Industry Keywords

PharmaceuticalBiotechCROHealth Outcomes ResearchMeasurement ScienceRegulatory GuidanceHTAPayer SystemsClinical TrialsEvidence-Based Medicine

About the role

Key responsibilities & impact

Support pre- and post-launch evidence-generating activities across Oncology products
Define and execute integrated evidence plans and oversee real-world evidence studies
Partner with Global Medical Affairs, Clinical Development, Regulatory Affairs, Market Access, HEOR, Biostatistics, and Safety
Provide methodological epidemiological and RWE leadership
Develop SOPs and guidance documents for timely, high-quality, fit-for-purpose evidence generation
Serve as a subject matter expert and build organizational capacity for RWE research
Lead global evidence strategy and RWE generation for oncology assets across the product lifecycle
Provide scientific and strategic leadership for RWE supporting regulatory, payer, clinical, and medical decision-making
Design Integrated Evidence Generation Plans and address evidence gaps
Shape evidence addressing regulatory, HTA, payer, clinician, and patient needs
Drive asset-level RWE strategy in partnership with Asset Teams
Critically review RWE and epidemiology studies designed by external providers and cross-functional partners
Ensure timely, high-quality epidemiology and RWE sections of worldwide regulatory documents
Support external licensing assessments with disease population analyses
Provide epidemiology support for clinical study design and planning
Engage with academic collaborators, patient registries, data partners, and methodological experts
Design prospective and retrospective pharmaco-epidemiology and RWE studies
Develop and adopt data-generation and analytical methodologies across lifecycle stages
Drive modern RWE methodologies and analytic techniques
Apply innovative study designs including pragmatic approaches, hybrid designs, external control arms, advanced causal inference, and longitudinal disease modeling
Oversee vendor-led and internally led RWE studies, including protocols, governance, timelines, quality, and budgets
Ensure methodological rigor, feasibility, scientific innovation, and regulatory acceptability
Use advanced statistical modeling, real-world data enrichment, data linkage, and exploratory machine-learning approaches
Partner with Biostatistics, Data Science, and external vendors on advanced analytics
Provide budget input and ensure projects are adequately resourced
Ensure RWE activities comply with SOPs, regulations, data privacy requirements, and ethical standards
Review study proposals and support global and local franchises
Link study data and external expert insights with Medical Asset Leads and Therapy Areas
Collaborate with Ipsen stakeholders on RWE topics and implement the RWE framework
Drive medical, cross-functional, and global alignment
Establish best practices for data generation and sharing

Requirements

What you’ll need

PhD or equivalent doctoral degree in Psychometrics, Psychology, Biostatistics, Health Outcomes Research, Measurement Science, or a closely related quantitative discipline
Extensive years of pharma experience in a related role
Significant industry experience in pharmaceutical, biotech, or CRO environments applying psychometric principles to drug development programs
Demonstrated track record of developing, validating, and/or implementing PRO instruments in clinical research
Hands-on experience designing and conducting studies to establish MCID/clinically meaningful change
Experience supporting regulatory, HTA, and payer-related evidence needs involving PRO data
Strong methodological and analytical skills
Knowledge of medical, regulatory, and payor systems in one or more regions of the world
Demonstrated experience designing and conducting PRO/psychometric studies supporting pre-/post-approval evidence generation
Expertise in development, validation, implementation, and interpretation of PRO instruments
Experience leading external analytic and evidence-generating activities
Experience conducting and designing studies around patient-reported outcomes
Excellent data analytic skills, including standard statistical software such as SAS and R
Exceptional critical thinking to identify gaps, analyze findings, make recommendations, and articulate next steps
Advanced knowledge of psychometric methods, including classical test theory and modern measurement approaches
Deep understanding of PRO endpoint strategy across clinical trials and real-world evidence
Familiarity with regulatory guidance related to PROs and patient-focused drug development
Fluent in English

Benefits

Comp & perks

Patient-focused workplace culture
Employee care and support
Growth opportunities and fulfilling challenges
Inclusive workplace committed to equality of opportunity
Application accommodations and support during the recruitment process