Director, Global Real-World Evidence & Health Outcomes Research Scientist- Hepat
JOB PURPOSE
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 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 Senior Director, Global Real-World Evidence & Health Outcomes Research for Hepatology therapeutic area 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 for hepatology 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.
Responsibilities
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
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Plan, design and execute multiple studies for a given asset and manage timelines, deliverables, and budget.
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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.
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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.
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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.
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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.
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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).
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Collaborate with internal teams and participate in best practice sharing sessions across NIS organization.
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Build strong working relationships with stakeholder groups across medical, market access, R&D and c