Director, Global Real-World Evidence & Health Outcomes Research-Modelling Vaccines

Job description Site Name: USA - Pennsylvania - Upper Providence, Belgium-Wavre, UK – London – New Oxford Street Posted Date: Oct 10 2024   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 the Modell i ng Lead is essential to ensuring that each medicine GSK brings to market is supported by scientifically credible, high quality, evidence aligned with the needs of decision makers responsible for granting access / reimbursement , whilst providing leadership in a particular therapy area .
The Director, Modelling work s in collaboration with colleagues across data generation , Medical, Biostat istics , E pidemiology , and other parts of GSK to apply specialized expertise in modelling to support a medicine and/or disease area regarding the development of HTA reimbursement strategy, core economic models (cost effectiveness and budget-impact) and robust methods for generating appropriate model data inputs.
The evidence generated from th is work inform s GSK drug development, support s HTA reimbursement submissions, inform s health care provider s , and ultimately , serves to transform clinical practice and improve patient outcomes.
Established as a focused global function, Data Generation & Scientific Communications, is uniquely placed to help accelerate the successful integration of our medicines and vaccines into the healthcare pathway – we're the 'engine' that brings our medical affairs strategies to life.
'Within this organization 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.' The role will serve as single point accountable Modelling Lead for a therapy area and / or mentor/ lead a team of high performing  health economists/ modellers .
The role will be accountable for ensuring close engagement with medical and matrix stakeholders and partner effectively in data generation plan (DGP) planning, design, execution, translation and dissemination for the asset and t o e nsure the highest standards of excellence are applied to modelling projects from a scientific /technical perspective .
The responsibilities listed below outline the scope of the position , but m ay vary, based upon evolving business needs.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following: Provide   management , and development of the TA Modelling team (as relevant), including 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.
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).
P ropose fit-for-purpose modelling/ HE solutions to asset and therapy area (TA) teams, the broader data generation / Medical community, and/or bring th e necessary expertise to a matrix team to proactively influenc e evidence generation through analytics, standards, innovation, and best practices.
Supervise the technical aspects of developing core economic models for medicines preparing for launch/HTA reimbursement applications, in cooperation with key individuals within CPO, Market Access and with vendors.
Lead development of global models for medicines preparing for launch/HTA reimbursement applications , alongside vendors as relevant , in c ollaboration with Medical, Development, data generation, Epidemiology, PCO.
Develop early economic models for pipeline products to be shared with product development teams to inform clinical development plans including Phase III trial design and real-world studies.
Serve as a member of the Modelling Protocol Review Committee to peer review modelling protocols submitted by global teams as well as LOCs seeking to undertake their own analyses.
Quality-assure economic modelling deliverables of external vendors, ensuring transparency and adherence to best-practice by recognized industry standards.
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 ) as relevant .
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.
Define and lead delivery of internal Modelling initiatives (e.g., technical or process improvement initiatives).
C ontribut e to GSK response to external draft HTA/ regulatory or other industry-wide initiatives about Modelling.
Maintain currency with innovat ive and novel methods for Modelling.
Develop standardized tools and templates to streamline the economic modelling development process and ensure minimum quality standards are met consistently.
Prepare relevant sections of documentation and communication for scientific advice meetings; participate and represent organization at such meetings .
Prepare abstracts and manuscripts as part of a defined Data Dissemination Plan for assets and to showcase any research developed over the course of supporting an asset or as independent methods research.
Participate in external engagement to stay abreast of best practices in economic modelling and create network of experts with whom to share innovations in methods.
Drive discipline in performance reporting and ensure studies are delivered according to plan and within budget.
L ead technical trainings, defin e best practice in analytics, and foster an environment of continued learning , as relevant.
Why you?
Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Advanced degree in a relevant health discipline, such as h ealth outcomes research, health economics, economics.
7+ years working in epidemiology, outcomes/health economics research, market access and/or and policy related to use of epidemiology, RWE, or health outcomes/economics for submission to regulatory agencies and/or HTAs within the biopharmaceutical industry, pharmaceutical services sector (consulting), and/or a regulatory agency.
Experience working within a business-driven environment, establish cross-functional relationships, balance priorities and handling of multiple tasks.
Leading partnerships with Commercial, Market Access and R&D functions.
Significant experience of independently led hands-on development of economic models within a consultancy environment, academia or pharmaceutical company.
Experience drafting technical reports for complex economic models with clear written English and attention to detail, including complete referencing using suitable referencing software or tools.
Experience leading the economic section of an HTA submission including an economic model in more than three markets.
Experience working in a fast-paced environment with multiple completing priorities Significant experience working within all MS office applications with a particular emphasis on Excel.
First authorship of publications detailing cost-effectiveness modelling research.
Experience working in multiple markets, including developing core deliverables aimed at adaptations to local country settings.
Experience conducting adaptations of economic models to local country settings, including validation of underlying clinical proposition as well as sourcing of model input   Experience with evolving HTA methodologies and health system environments.
Drug development processes and strategies experience meeting project and business objectives.
Preferred Qualifications: If you have the following characteristics, it would be a plus: Self-motivated with the ability to work independently to develop credibility with colleagues within and outside of CPO .
Excellent communication skills to interact effectively in multi-disciplinary matrix teams and to influence global stakeholders and key opinion leaders.
Please visit  GSK US Benefits Summary t o learn more about the comprehensive benefits program GSK offers US employees.
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 the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).
Our success absolutely depends on our people.
While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive.
We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be.
A place where they can be themselves – feeling welcome, valued, and included.
Where they can keep growing and look after their wellbeing.
So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
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