Real World Evidence Medical Lead

at  Sanofi US

EXPERIENCE:

• End-to-end leadership of RWE studies from concept to study completion and publication for regulatory or reimbursement submissions.
• Analysis of data needs and/or data sources for a disease area or pharmaceutical product.
• Proven experience in the field of clinical/epidemiology/public health with expertise in developing epidemiological studies.
• Demonstrated experience in strategic evidence generation.
• Significant peer reviewed publication track record in epidemiology, clinical and statistical and/or HEOR journals required.
• Experience working in multiple therapeutic areas: transplant, type 1/2 diabetes or cardiovascular, Immunology, Rare Diseases and/or Hematology highly preferred.
• Demonstrated network collaboration experience, including with complex global matrix teams.

Languages:

• Fluent in English and Italian.

Soft skills:

• Ability to effectively cooperate cross-functionally as as strong team player
• Excellent written and oral communication skills: ability to influence and negotiate positively and constructively.
• Attention to details.
• Collaborative, able to manage stakeholder relationships at glocal level.
• Apply growth mindset to develop new skills or knowledge.
• Demonstrated strong strategic thinking and strategic approach to problem-solving.
• Systematic thinking and focus on impact.
• Strong sense of urgency, ownership and proactive attitude to deliver value to our brands.

Technical skills:

• Expert knowledge in RWE, pharmaco-epidemiology, health outcomes research or data science.
• Ability to build an evidence strategy from business needs and translate into study requirements.
• Demonstrated ability to critically assess data, methods and study designs, and relate those aspects to evolving product strategy.
• End-to-end project management of real-world studies and management reporting.
• Proficiency in evaluating data sources to determine fit-for-purpose.
• Good working knowledge of the commercial strategy (i.e. market share, competitors, product positioning) and ability to adapt evidence strategy in anticipation of market changes.
• Strong portfolio management skills to manage multiple concurrent projects.

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As a member of the Medical Team and contributor to the medical evidence generation community, the RWE Medical Head builds on training and experience in health sciences and epidemiology research, public health, and regulations to ensure that relevant medical evidence is available and strategically used to support the development, launch and commercialization of drugs/vaccines throughout the entire product lifecycle, in the designated TA scope.

• Be the local medical RWE expert and central connection with global RWE experts to ensure excellence in execution on brand RWE strategies, especially for pre-launch periods and launch brands, data strategies and RWE transformational initiatives.
• Develop and implement strategies for the identification, collection, evaluation and analysis of real-world data (RWD) sources in the MCO/country, to support various research initiatives and business objectives at MCO level, aligned with global brand and RWE strategies.
• Collaborate cross-functionally with internal stakeholders including clinical research units, medical affairs, market access, and commercial teams to identify research questions and generate evidence-based insights.
• Design and oversee observational studies, registries, and other real-world evidence-generating activities, including retrospective analysis of existing databases, ensuring compliance with regulatory requirements and ethical standards.
• Identify and evaluate local data gaps and opportunities in partnership with the global RW Data Strategy & Partnership Lead and Evidence Strategy Leads, that is fit-for-purpose to identified evidence gaps from brand IEGPs and the RWE data strategy.
• Manage relationships with external vendors, including contract research organizations (CROs), data providers, and academic institutions, to facilitate data acquisition, processing and analysis.
• Lead the analysis and interpretation of real-world data, employing advanced statistical methods and epidemiological techniques to derive meaningful insights, in collaboration with internal and external experts.
• Participating in external scientific engagement and maintaining at MCO level, to facilitate the collection of insights, challenges and best practices, as well as to deliver opportunities to shape the external acceptability of RWE.
• Prepare and present findings from real-world evidence studies to internal and external stakeholders, including scientific conferences, ministries of health, regulatory agencies, and healthcare providers.
• Lead the local upskilling of RWE with global initiatives, events and learning opportunities, coordinated with the global upskilling in RWE strategic initiative. Create and organize local activities to enhance learner motivation and deliver an effective learning experience.
• Stay abreast of developments in real-world evidence methodologies, advances in data science, regulatory guidance, and healthcare data trends, and integrate relevant insights into project planning and execution.
• Contribute to the development of real-world evidence strategies relevant to the MCO and integrated evidence generation plans to support product development, regulatory submissions, and market access efforts.
• Represent global RWE in country medical leadership team to facilitate seamless communication, coordinate and alignment of RWE with medical strategies and changing business needs.
• Provide guidance and support to cross-functional teams on the use and interpretation of real-world evidence in decision-making processes.
• Drive the timely execution of the RWE operational plan.
• Foster a culture of evidence-based decision-making by promoting the value of real-world data and evidence within the organization and with external stakeholders, work on the development of local databases if relevant

As a member of the Medical Team and contributor to the medical evidence generation community, the RWE Medical Head builds on training and experience in health sciences and epidemiology research, public health, and regulations to ensure that relevant medical evidence is available and strategically used to support the development, launch and commercialization of drugs/vaccines throughout the entire product lifecycle, in the designated TA scope.

• Be the local medical RWE expert and central connection with global RWE experts to ensure excellence in execution on brand RWE strategies, especially for pre-launch periods and launch brands, data strategies and RWE transformational initiatives.
• Develop and implement strategies for the identification, collection, evaluation and analysis of real-world data (RWD) sources in the MCO/country, to support various research initiatives and business objectives at MCO level, aligned with global brand and RWE strategies.
• Collaborate cross-functionally with internal stakeholders including clinical research units, medical affairs, market access, and commercial teams to identify research questions and generate evidence-based insights.
• Design and oversee observational studies, registries, and other real-world evidence-generating activities, including retrospective analysis of existing databases, ensuring compliance with regulatory requirements and ethical standards.
• Identify and evaluate local data gaps and opportunities in partnership with the global RW Data Strategy & Partnership Lead and Evidence Strategy Leads, that is fit-for-purpose to identified evidence gaps from brand IEGPs and the RWE data strategy.
• Manage relationships with external vendors, including contract research organizations (CROs), data providers, and academic institutions, to facilitate data acquisition, processing and analysis.
• Lead the analysis and interpretation of real-world data, employing advanced statistical methods and epidemiological techniques to derive meaningful insights, in collaboration with internal and external experts.
• Participating in external scientific engagement and maintaining at MCO level, to facilitate the collection of insights, challenges and best practices, as well as to deliver opportunities to shape the external acceptability of RWE.
• Prepare and present findings from real-world evidence studies to internal and external stakeholders, including scientific conferences, ministries of health, regulatory agencies, and healthcare providers.
• Lead the local upskilling of RWE with global initiatives, events and learning opportunities, coordinated with the global upskilling in RWE strategic initiative. Create and organize local activities to enhance learner motivation and deliver an effective learning experience.
• Stay abreast of developments in real-world evidence methodologies, advances in data science, regulatory guidance, and healthcare data trends, and integrate relevant insights into project planning and execution.
• Contribute to the development of real-world evidence strategies relevant to the MCO and integrated evidence generation plans to support product development, regulatory submissions, and market access efforts.
• Represent global RWE in country medical leadership team to facilitate seamless communication, coordinate and alignment of RWE with medical strategies and changing business needs.
• Provide guidance and support to cross-functional teams on the use and interpretation of real-world evidence in decision-making processes.
• Drive the timely execution of the RWE operational plan.
• Foster a culture of evidence-based decision-making by promoting the value of real-world data and evidence within the organization and with external stakeholders, work on the development of local databases if relevant.