Associate Director, Global Real-World Evidence

Reference #: 404936 Site Name: USA - Pennsylvania - Upper Providence, Belgium-Wavre, Cambridge MA, UK - London - New Oxford Street, USA - Maryland - Rockville Posted Date: Oct 8 2024

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.

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 Associate Director, Global Real-World Evidence & Health Outcomes Research, Evidence Synthesis 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.  Associate Director, Evidence Synthesis works in collaboration with colleagues across Data Generation, Medical, Biostatistics, Epidemiology, and other parts of GSK to design and implement quantitative evidence syntheses (e.g., indirect treatment comparisons, network meta-analysis, external comparator arm analyses) for GSK medicines. The evidence generated from this work informs GSK drug development, supports regulatory and HTA reimbursement submissions, informs health care providers, and ultimately, serves to transform clinical practice and improve patient outcomes.

SPECIFIC RESPONSIBILITIES: The role will serve as single point accountable Lead for a therapy area or some key asset projects. 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 to ensure the highest standards of excellence are applied to quantitative evidence synthesis projects from a scientific/technical perspective. Further, to ensure these studies are in full compliance with GSK standards and processes, and requirements from health authorities. The responsibilities listed below outline the scope of the position. The application of these tasks may vary, based upon evolving business needs.

Design and Analysis

Propose fit-for-purpose evidence synthesis solutions to asset and therapy area (TA) teams, the broader VEO / Medical community, and/or bring the necessary expertise to a matrix team to proactively influence evidence generation through analytics, standards, innovation, and best practices

Consult and advise on the approach to identify and compile the data s urces (e.g., systematic literature review) required to conduct quantitative synthesis

Lead or oversee quantitative evidence synthesis feasibility assessments and recommend the most suitable analytic approach(es)

Lead or oversee specific elements (methods, design, analytics, sample/size) of protocols (or entire protocols themselves) of increasing complexity during development

Lead or oversee implementation of the following analyses (not an exhaustive list): Bayesian network meta-analysis (including non-proportional hazard methods), meta-regression, population-adjusted indirect treatment comparison (including matching-adjusted indirect comparison, simulated treatment comparison, and multi-level network meta-regression), IPTW and more innovative weighting approaches, survival analysis (including flexible and innovative methods not limited to landmark survival analysis and methods for incorporating external data), and quantitative bias analysis

Lead or oversee quality control (QC) of work products

Define and lead delivery of internal Evidence Synthesis initiatives (e.g., technical or process improvement initiatives)

Contribute to GSK response to external draft HTA/ regulatory or other industry-wide initiatives about Evidence Synthesis

Maintain currency with innovative and novel methods for quantitative evidence synthesis Communication of Results

Co-author scientific publications, especially the methodological/statistical sections

Present research results to study team and other collaborators, including results interpretation and drawing appropriate inferences based on study design/statistical methods as well as assessment of study limitations

Explain technical concepts at all levels in the organization, including senior leadership/stakeholders

Successfully negotiate with senior management on issues which are high risk to the business

Inform/influence TA/asset strategy Leadership and Teamwork

Manage projects to ensure delivery of a portfolio of high-quality work to agreed timelines

Proactively influence team members regarding appropriate research/statistical design and analytics delivery through various engagement forums

Manage relationships with vendors and hold them accountable to meet GSK standards

Mentor team members, facilitate the development of others, and help solve day-to-day challenges

Maintain awareness/understanding of roles of partner departments leading to enhanced contributions through collaboration.

Anticipate and communicate potential problems at study or functional level and lead solutions to resolve TECHNICAL SKILLS:

Apply expert understanding of study design, sources of potential bias, methodology, and statistics to deliver quantitative evidence synthesis projects

Apply innovative, fit-for-purpose methodology and approaches to solve critical problems

Proficient in a relevant programming language (e.g., R, BUGS/JAGS, STAN).

Develop in-depth knowledge on the assigned asset(s) SOFT SKILLS:

Merge scientific thinking and business knowledge to identify issues, evaluate options, and implement solutions

Strong problem-solving skills, ability to address conflicts/issues and make decisions to achieve results

Ability to work with a minimum amount of supervision and interact with matrix partners across the organization

Ability to anticipate problems related to assigned work or areas of expertise and able to implement solutions, proactively seeking input from supervisor/manager if needed

Excellent oral and written communication skills

Excellent organizational and planning skills

BASIC QUALIFICIATIONS:

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