Director, Patient-Focused Evidence Global (remote)
Millipore Corporation

Job Info

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As a Director for Patient-Focused Evidence working at a global level, you will lead the development of evidence strategies to capture and integrate the patient's perspective and patient experience data into drug research and development programs to address evidentiary requirements of health authorities and other stakeholders, supporting the end goal of patient access for EMD Serono's products. Key responsibilities: Lead the development of evidence-generation strategies for collecting and integrating patient experience data and patient perspectives in programs in close collaboration with key internal and external stakeholders. Lead the development of clinical outcome assessment (COA) measurement strategies, including the development of conceptual models, the selection, development, and validation of COA measures and endpoints.Contribute to program Integrated Evidence Plans (IEPs) and other key program deliverables by facilitating consideration and inclusion of key patient experience aspects and related evidence gaps. Contribute to the design and implementation of clinical studies (COA aspects), including study design, protocol writing, endpoint definition, data analysis planning, study report development, and dissemination. Contribute to patient engagement activities related to program strategy or clinical studies, including patient advisory boards, panels or councils.Serve as subject matter expert in applying mixed-methods, qualitative, and quantitative research techniques to address key business and research questions related to patient's experience across all drug research, development, and commercialization lifecycle phases.Ensure high impact for deliverables by understanding business priorities and focusing on customer needs within a matrix organizational structure. Build, maintain and strengthen internal and external expert networks to anticipate, understand and/or inform changing evidence requirements from key external healthcare decision-makers. Present research findings at national and international congresses and publish articles in scientific journals.Maintain awareness of relevant new scientific, methodological, and regulatory developments. Manage project-related contracting, budgets, vendor/partner oversight and management.

Who you are:

Minimum Qualifications:

Master's degree in socio-behavioral sciences or health outcomes measurement e.g., health outcomes research, psychology, behavioral sciences, ethnography, or psychometrics.At least five years of experience working in the patient-centered research field within the life science industry, research organizations, academia, or consulting.Deep understanding of current regulatory and relevant professional societies' guidance on Patient-Focused Drug Development and the integration of patient experience data in drug research, development and commercialization.Demonstrable experience in leading the development or validation of new COAs, including clinician-reported outcomes (ClinROs), patient-reported outcomes (PROs), observer-reported outcomes (ObsROs), performance outcomes (Perfos), and digital clinical measures.Demonstrable experience in leading the preparation of COA evidence dossiers for submission to health authorities to support drug development programs or COA measure qualification

Preferred Qualifications:

Doctoral degree in socio-behavioral sciences or health outcomes measurement e.g., health outcomes research, psychology, behavioral sciences, ethnography, or psychometrics.Knowledge of research methodologies and analytical principles relevant in clinical research e.g., ICH guidelines, good research practices in observational studies, and the ESTIMAND framework.Demonstrable experience applying novel approaches to generate patient-focused evidence, e.g., applying natural language processing to collect data on social media.Demonstrable conceptual, methodological, and analytical skills. Curious, innovative and solution-focused mentality.Strong stakeholder management and communication skills, within cross-functional teams, across organizational hierarchies and cultural and geographical boundaries. Location: Position is remote and can be located anywhere in the world

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