Senior Director, Global Real-world Evidence
il y a 3 semaines
**Site Name**: UK - London - New Oxford Street, Belgium-Wavre, USA - Pennsylvania - Upper Providence
**Posted Date**: Sep 23 2024
**Senior Director, Global Real-World Evidence & Health Outcomes Research Lead - Pneumococcal MAPS**:
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 Senior Director, Global Real-World Evidence & Health Outcomes Research Lead is critical to achieving this ambition by ensuring 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 essential for the alignment of evidence with the requirements of customers responsible for marketing authorization, recommendation and reimbursement leading to successful patient access, product use and commercial success.
Within this organisation as the VP, Head of Global Real-World Evidence & Health Outcomes Research, Sulabha Ramachandran will be leading a team which incorporates the legacy VEO/Non-Interventional Studies capabilities teams under a newly evolved name that more closely reflects their purpose and the research they deliver.
**Key Responsibilities include, but are not limited to**:
The role will serve as single point accountable lead for a medium complexity priority asset and will have expertise in real-world evidence and other non-interventional study methods. The role will be a key member of the Global Real-World Evidence & Health Outcomes Research Therapy Area LT and other relevant matrix leadership teams. The Director, Global Real-World Evidence & Health Outcomes Research Lead 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 for the asset.
- Provide leadership, management, and development of the asset team, including recruitment and capability building, support, and development opportunities through best practice sharing to create high performing, quality assured resources which support the business.
- Partner effectively with matrix stakeholders in planning and design of the DGP for the asset, drive disciplined execution of studies and activities, translate results, and disseminate data and research findings to all relevant internal and external stakeholders.
- Provide guidance for best practice in real world evidence/ NIS methodologies, including enabling external scientific advice, ensuring appropriate protocol review committee’s advice sought and incorporated.
- Drive innovation and inform ideas and options through effective engagement with external experts, clinical guideline groups, HTA agencies, methodology and policy forums, and by leveraging knowledge of the external policy and decision maker environment to enable more efficient evidence development for the asset across the lifecycle (e.g. discovery, launching and life cycle management assets)
- Integrate excellent understanding of the evolving global NITAG, Health Technology Assessment, clinical guidelines groups, policy decision makers and payer environment, including recommendation, reimbursement, pricing, and access in relevant therapy area.
- Negotiate with key stakeholders as to what evidence for the asset is and is not developed, weighing risks and benefits to optimize reimbursement opportunities, support scientific exchange and clinical guideline development.
- Deliver the materials to inform internal governance decision making (e.g. Medical Review Board, etc)
- Facilitate alignment and partnership to enable more effective interactions within the complex stakeholder matrix, e.g. clinical, commercial, market access, medical affairs functions, priority market LOCs as well as external third-party suppliers.
- Represent GSK in external collaborations, engagement and scientific evidence requirements with scientific partners, reimbu
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