Description
**ROLE SUMMARY**
The Platform: The Chief Medical Affairs Office's Real World Evidence (RWE), VP Lead Oncology 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 RWE, Patient Advocacy and External Collaboration team fully centralizes RWE, epidemiology, outcomes research, RW-relevant health informatics, and biostatistics talent from global, international developed market (IDM) and emerging markets (EM) into one team to drive efficiency through internalized work while building processes to insure representation from multiple stakeholders, particularly patients.
The team 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.
RWE, other patient-centric evidence, and RWI will be generated by the Platform for all global, prioritized needs through 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 opportunity:** The RWE Oncology Team is responsible for RWE generation for oncology and oncology-related assets. They will conduct studies to support the Integrated Evidence Plans (IEP) and strategic goals of all regions including IDM and EM. All study types are within remit including regulatory and non-regulatory Research Collaborations, interventional studies, non-interventional, low interventional, pragmatic, registries and epidemiological studies. This team will foster the design and lead the execution of retrospective RWE generation using retrospective RWD sources or technology based direct from patient approaches for observational, hybrid interventional/RWE trials and other approaches. This team will partner to develop enterprise integrated evidence plans and provide ongoing support of the scientific and operational working groups of the GMAT Evidence generation subcommittee. Alongside platform partners, this team will foster patient engagement across the life cycle of the oncology assets. This team will work to understand and translate RWE strategies into actionable project plans and ensure high quality and timely delivery of compliant RWE and insights, partner to ensure sound integrated evidence planning, including incorporation of key stakeholders (ex: patients), development of necessary RWE methods and the evidence generation working groups of the GMAT.
The RWE Oncology Lead responds to the dynamic business needs to ensure appropriate resourcing across all assets and regions to deliver innovative, high-quality, cost efficient, clinical and epidemiological studies. Along with the other platform teams, the RWE Oncology Team Lead will build collaborative bridges to provide high quality support for development and execution of oncology RWE studies in the US and International priority markets addressing oncology-related therapeutic areas and products in line with the enterprise needs.
The RWE Oncology Lead will be responsible for developing and leading teams that focus on working closely with CMAO and POD oncology teams to thoroughly understand their strategy, partner to carry through integrated evidence plans, help develop tactics, and design and execute strategically focused, non-interventional and low-interventional studies. They will work with teams to develop an understanding of the benefits and limitations of various real-world data (RWD) sources through cross-functional partnership with the Platforms and Partnerships team. This role leads a team of ~15 Sr Director through Manager-level RWE Science & Epidemiologists, Clinical Scientists & Clinical Operations colleagues. This Head's leadership team will serve as single points of contact for RWE oncology needs as articulated in Integrated Evidence Plans, GMAT governance and project plans. To do so, the head develops KPIs and success metrics with each of their therapeutic area-aligned teams and other Platform colleagues. They then direct their teams to work in highly-matrixed cross-functional teams to design study concepts, draft protocols that are robustly designed, leverage knowledge of RWD and data standards, incorporate knowledge of standard of care and endpoints for given categories, ensure high quality SAPs, and deliver RWE to teams for interpretation and dissemination. The lead will also direct their teams to rapidly communicate successes, publications, external speaking engagements, and lessons learned to the EvGen Impact Translation leader will also work across other senior leaders and category aligned RWE teams, RWE Primary and Specialty Care, RWE Clinical Affairs & Clinical Operations, Study Quality Control & Compliance, and RWE Platforms & Partnerships.
Outside of the Platform, the RWE Oncology Lead will work with leaders from Biostatistics & Data Management, Global Regulatory Affairs, Clinical Pharmacology / Pharmacometrics, HEOR, Legal/Compliance, and others to achieve research and business objectives. They will also serve as an external face for study execution to Pfizer, providing expert epidemiological, statistical, methodological and execution excellence knowledge to its leaders. They will also serve as a trusted expert with study / analytical KOLs, key regulatory agencies (e. g., FDA in the US, EMA in Europe, MHRA in the UK, PDMA in Japan, CDE in China), HTAs/Payers, and other stakeholders. They will be responsible for working with cross functional partners and our integrated evidence planning team to generate integrated evidence plans, determining the best methodological approaches and study designs, providing feedback on tactic and project feasibility, selecting appropriate real-world databases and ultimately for delivering upon all in scope evidence. They will monitor their teams' performance and re
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