Hematology RWE Science & Epidemiology Director

ROLE SUMMARY

The Platform: The Chief Medical Affairs Office’s Real World Evidence (RWE) Platform is responsible for establishing global scientific leadership and stature through the generation of integrated, end-to-end observational real-world evidence serving all therapeutic areas from proof of concept (POC) trials through LOE for priority pipeline candidates, pipeline supplementation through business development, and marketed inline products. The Platform fully centralizes RWE, epidemiology, outcomes research, RW-relevant health informatics, and biostatistics talent from global, US, and international markets into one team to drive efficiency through internalized work.
 

The Platform functions to:
enhance Pfizer’s ability to determine unmet medical needs; support differentiated product labels for Product Development programs including finding alternatives and accelerated licensure pathways for new indications through the use of Real World Data (RWD), Real World Insights (RWI) and Real World Evidence (RWE); inform clinical practice on appropriate prescription and use of Pfizer’s products; in collaboration with Access & Value, strengthen the value evidence package for payers and access/policy decision-makers; support measurement of short- and long-term impact of Pfizer’s products to both patients and populations; support competitive differentiation.
The Opportunity: This role will be responsible for intaking franchise and asset integrated evidence plans and tactics, then delivering high quality RWE, RW insights or other patient-centric evidence for prioritized projects to fully the tactic or strategic pillar, working with the RWE Strategic Planning teams.

The remit spans from global and prioritized international markets, where the evidence will be used to respond to regulatory commitments / requests, HTA/government entity needs and key projects that have been prioritized in a managed work queue by the global medical strategy committee. The role is highly technical and will execute hands-on evidence generation via a combinatorial approach of cutting edge retrospective data analyses, site-based evaluations (e.g., Phase IV observational effectiveness studies, burden of illness, transmission, pathogenesis, risk factors for illness, determinants of product effectiveness and other studies), application of novel methods and technologies, and supplementation of interventional trials where appropriate with RWE through hybrid trial designs and tokenization.  The Platform will insource this work to the fullest possible extent, so prospective candidates who have solely outsourced work to contract research organizations need not apply.

Within the RWE Platform, a dedicated team of RWE Scientists will support the TA teams within the Hematology category, reporting to the Hematology RWE Science & Epidemiology Team Lead. Leveraging their understanding of how RWE can support the entire lifecycle from molecule to marketplace, the Hematology RWE Science & Epidemiology Director will deliver timely real world insights (RWI) by understanding cross-functional pipeline / asset team’s strategic objectives and timelines, collaborate with the team and RWE Biostatistics & other relevant colleagues to generate RWE, and direct creation of easy-to-understand summary reports. They act as an RWE expert, advising on what type of real world data and which sources are most appropriate for completing objectives, partnering closely with the Platforms & Partnerships and Patient Advocacy & External Partnerships teams. The RWE Scientist will ensure the development of consistent business rules and standards, versioning rules as care pathways evolve.
 

ROLE RESPONSIBILITIES

• Execute on prioritized tactical plans with actionable projects, identify external partners to deliver strategic RWE capabilities / data, and oversight of high quality methods and designs to inform study / project designs for R&D franchise / asset teams, CMAO, Health Economics and Outcomes Research, Commercial and other functions’ needs

• Develop project plans and protocols for the assigned franchise / asset team(s), apply high quality methods and designs to inform insights and RWE studies, generate credible RWI, and high-quality, protocol-driven RWE studies

• Provide daily mentorship, motivation, and guidance to more junior Hematology RWE colleagues, & direct them to co-develop of business rules, standards (e.g. for disease / cohort definitions), methods and SOPs with cross-functional colleagues

• Conducts feasibility assessments to determine appropriate internal / external real world data sources and directs creation of RWI for internal insights informing go/no-go decisions, hypothesis generation, and decision-making for executives, teams and business development

• Coordinates cross-functional teams, RWE Bi