Director, Global Real-World Evidence & Health Outcomes Research Scientist, Specialty Pipeline

For drugs to be successful, there must be robust health outcomes data to support launch optimization, reimbursement and maintain market position. Specifically, evidence must be maintained throughout the product lifecycle as standard of care changes, new competitors are introduced, and patents expire on existing competitors. The landscape is evolving quickly as trials demonstrating efficacy in an area of unmet need may receive expedited review, or orphan product status designation which affects both GSK and competitors launch timelines and approval requirements. More and more of our customers are developing sophisticated internal health outcomes capabilities and access to real world data that can be used to better understand unmet needs and real-world effectiveness of our medicines. We need to better understand how our customers define value and to effectively collaborate with them to ensure we are generating value evidence data that includes real world evidence and cost effectiveness analysis that is impactful for payers, health systems, providers, and patients. The role of Director, Global Real-World Evidence & Health Outcomes Research Scientist, Specialty Pipeline is critical to achieving this ambition by supporting asset teams to ensure that each medicine GSK brings to market is supported by scientifically credible, high quality, evidence that drives competitiveness and strong evidence-based product positioning, value propositions and value-based pricing. The role is critical to support the alignment of evidence with evidentiary requirements of customers responsible for marketing authorization, recommendation and reimbursement leading to successful patient access, product use and commercial success. The role will report directly into the Global Real-World Evidence & Health Outcomes Research Specialty Pipeline Lead and will have expertise in real-world evidence and other non-interventional study methods. The role will be a key member of asset team and other relevant matrix leadership teams. The Director, Global Real-World Evidence & Health Outcomes Research Lead Scientist, Specialty Pipeline will be accountable for engaging closely with medical and matrix stakeholders and partner effectively in data generation plan (DGP) planning, design, execution, translation and dissemination at the study level for the asset. Ready to shape the future of healthcare? Key Responsibilities include, but are not limited to:

• Plan, design and execute multiple studies for a given asset and manage timelines, deliverables, and budget.
• Assure quality of deliverables, including review and sign off project specifications, protocols, data analysis plans, final study reports, abstracts, posters and manuscripts, adherence to SOPs.
• Identify resources, references and analyses to inform scientific design and advise internal experts (clinical, commercial/market access) and external experts as needed in support of the asset team.
• Translate identified needs for evidence into study concepts in alignment with strategic objectives and vision for the asset, e.g. development of study protocols and proposing innovative and cost-effective ways of developing and executing studies.
• Develop and maintain a good working knowledge of real-world data resources, existing partnerships and public initiatives and become the point person for select sources to advise on their suitability to address given research questions.
• Develop a deep understanding of customers' needs, including HTA requirements, as well as the of acceptance of RWE or economic evidence and impact to the decision making of different customers (reimbursement, medical societies, physicians)
• Collaborate with internal teams and participate in best practice sharing sessions across NIS organization.
• Build strong working relationships with stakeholder groups across medical, market access, R&D and commercial to ensure strategic alignment and optimal cross-functional collaboration and communication.
• Ensure key stakeholders including TA aligned business leaders are regularly updated on plans through periodic reporting.
• Develop excellent working relations with external thought leaders to ensure appropriate methods and research agendas are applied, in accordance with GSK policies., We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.
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• MSc, or equivalent in health outcomes, patient reported outcomes, health economics, epidemiology, pharmacy, health or life sciences.
• Proven experience working in pharmaceutical industry, preferably in a multi-national company.
• Demonstrated ability to plan and deliver individual projects, manage budgets and work within matrix setting.
• Experience with a variety of study designs, i.e. RWE studies including prospective, cross-sectional and retrospective cohort studies.
• Applied experience in utilizing evidence for the development of HTA submissions, reimbursement and/or medical engagement.
• Methods expertise to effectively deliver robust payer evidence and credibility to engage meaningfully with external experts & leaders in the field.
• Knowledge of the diversity and complexity of healthcare markets, health technology assessment agencies, and reimbursement decision making globally, in region and in local markets.
• Understanding of how health economics, health outcomes, comparative effectiveness research, PRO research and the use of PRO instruments can be applied at local decision-making levels, including support of clinical practice.
Preferred Qualifications:
• Advanced scientific degree, e.g. PhD, PharmD or equivalent in health outcomes or similar.
• Experience of strategic evidence planning prior to Phase 3.
• Self-motivated with the ability to work independently and develop credibility with colleagues throughout the enterprise.
• Ability to communicate technical and complex concepts and results effectively to various audiences to impact decision-making.
• Experience in above country and in country roles
• Direct Payer experience.
• Launch experience.
  
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