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GlaxoSmithKline LLC Senior Director, Global Real-World Evidence & Health Outcomes Research Lead - RS in Collegeville, Pennsylvania

Reference #: 404885 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 - RSV

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. 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, a d 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, reimbursement bodies and other decision makers. Drive quality and compliance through team to ensure trust for the evidence that is delivered. Drive discipline in performance reporting and ensure studies are delivered according to plan and within budget. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: PhD, PharmD or equivalent level qualification in Health outcomes, patient reported outcomes, health economics, epidemiology, pharmacy, health, or life sciences. Considerable experience working in global pharmaceuticals in a leadership role. Methods expertise to guide and lead team in delivering robust payer evidence deliverables 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. Deep knowledge and strong communication skills are critical for interpreting and translating complex concepts and results effectively to a variety of audiences to impact decision making. Excellent knowledge of drug development and therapy area. Self-motivated with the ability to work independently and develop credibility with colleagues throughout the enterprise. Experience leading a portfolio of projects and influencing senior stakeholder groups.Preferred Qualifications:  If you have the following characteristics, it would be a plus: Advanced scientific or business degree specialized in Health Outcomes or similar. Experience in above country and in country roles. Direct Payer experience. Launch experience. Portfolio of high value publications and/or scientific promotions. Closing Date for Applications: 7th October 2024 (EOD)

Please take a copy of the Job Description, as this will not be available post closure of the advert. When applying for this role, please use the 'cover letter' of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.

Why GSK? Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and

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