Group Medical Evidence Generation Lead Lazio

Group Medical Evidence Generation Lead
Roma
Lazio, Lazio

Job PurposeResponsible for keeping oversight of evidence generation activities across the two BUs and all therapeutic areas.

This role supervises the real-world evidence (RWE) data generation and communication strategy/plans. Facilitate the implementation of a strong culture of strategic evidence generationEnsure brands in development and in markets have a robust evidence base, including patients and outcomes data when possible, to support their value and safetyBridge the gap between clinical research, real-world evidence, and market access, contributing to the successful development and commercialization of company's productsAs a subject matter expert, work closely with Medical Affairs, R&D, Marketing, Market Access and other relevant functions, as appropriate, to co-create and execute evidence generation strategies and plans that align with regulatory requirements, market access needs, and the overall product development and brands communication plans Design, coordinate, and oversee the generation of evidence, including outcome research, throughout the product lifecycleIdentifies global and local opportunities for RWEKey ResponsibilitiesEvidence Generation Strategy/Plans: Develop and implement evidence generation strategies and plans for medical products, ensuring they meet regulatory requirements and market access needs, in line with BU/Franchise strategy and prioritiesKOL / External stakeholders partnership: in collaboration with medical teams, engage with key scientific leaders / Societies and other relevant external stakeholders (healthcare professionals, digital, administrative) to identify unmet medical need and research gaps and opportunities.

Identify opportunities for global and local evidence generation in priority areas. Real-world Evidence: Drive internal RWE awareness and trainings to enhance local capabilities in generating real-world evidence and local publications.

Utilize real-world data sources (e. g. , electronic health records, claims data), and plan non -interventional trials ( NIS ) and other types of studies to generate evidence on product effectiveness, safety, and value in real-world clinical settings. Health Economics and Outcomes Research (HEOR): In collaboration with market access teams, design and conduct HEOR studies to assess the economic impact and patient outcomes associated with the product.

This may include cost-effectiveness and budget impact analyses. Marketing and Market Access Support: Collaborate with marketing and market access (and other as appropriate) teams, both at corporate, franchise and local level, to provide evidence needed for reimbursement and market adoption of the product. Data Analytics: Apply advanced data analytics techniques to analyse and interpret complex healthcare data, supporting evidence generation efforts. Regulatory Compliance: Ensure that evidence generation activities adhere to clinical and regulatory guidelines and requirements set forth by health authorities (e. g. , FDA, EMA). Publication and Communication: Drive the development of scientific publications, presentations, and dossiers that communicate evidence to internal and external stakeholders. Cross-functional Collaboration: Work closely with medical affairs, clinical development, regulatory affairs, and other relevant teams to align evidence generation efforts with overall product strategy and priorities. Medical governance and Compliance: Ensure activities are done in compliance with company's corporate standards, industry regulations, guidelines, and ethical standardsRequired EducationAdvanced degree (Ph. D. , M. D. , Pharm. D. , or equivalent) in a relevant field such as epidemiology, health economics, clinical research, or a related disciplineRequired Skills and ExperienceAdvanced degree (Ph. D. , M. D. , Pharm. D. , or equivalent) in a relevant field such as epidemiology, health economics, clinical research, or a related discipline. At least 7 years of experience in evidence generation within the healthcare or pharmaceutical industry. Solid knowledge of medical affairs, clinical trial design, real-world evidence, health economics, and regulatory requirements. Solid understanding of data analysis and statistical methods. Effective communication and presentation as well as leadership skills. Knowledge of relevant software and tools for evidence generation and analysis. Required LanguagesFluency in written and spoken English