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Vice President of Real World Evidence in Oncology

2 months ago

San Francisco, California, United States Pfizer Full time

POSITION OVERVIEW

The Vice President of Real World Evidence (RWE) for Oncology at Pfizer is tasked with establishing global scientific authority and recognition through the creation of comprehensive, end-to-end observational real-world evidence across all therapeutic domains. This includes the management of proof of concept (POC) trials, pipeline enhancements via business development, and support for marketed products.

The RWE, Patient Advocacy, and External Collaboration team consolidates expertise in RWE, epidemiology, outcomes research, health informatics relevant to real-world scenarios, and biostatistics from both developed and emerging markets. This structure aims to enhance efficiency while ensuring diverse stakeholder representation, particularly from patients.


TEAM OBJECTIVES:
  • Improve Pfizer's capacity to identify unmet medical needs.
  • Facilitate differentiated product labeling for Product Development initiatives, including exploring alternatives and expedited licensure pathways for new indications utilizing Real-World Data (RWD), Real World Insights (RWI), and Real-World Evidence (RWE).
  • Guide clinical practice regarding the appropriate prescription and utilization of Pfizer's offerings.
  • Collaborate with Access & Value to enhance the value evidence package for payers and policy decision-makers.
  • Assess the short- and long-term impacts of Pfizer's products on patients and populations.
  • Support competitive differentiation.

The RWE Oncology Team is dedicated to generating RWE for oncology and related assets. They will conduct studies that align with the Integrated Evidence Plans (IEP) and strategic objectives across all regions.

All types of studies fall within their scope, including regulatory and non-regulatory Research Collaborations, interventional, non-interventional, pragmatic studies, registries, and epidemiological research.

This team will lead the design and execution of retrospective RWE generation utilizing retrospective RWD sources or technology-driven patient approaches for observational and hybrid interventional/RWE trials.

They will partner in developing enterprise-wide integrated evidence plans and provide ongoing support to the scientific and operational working groups of the GMAT Evidence generation subcommittee.

In collaboration with platform partners, this team will promote patient engagement throughout the lifecycle of oncology assets.

The RWE Oncology Lead will adapt to evolving business needs to ensure adequate resource allocation across all assets and regions, delivering innovative, high-quality, and cost-effective clinical and epidemiological studies.

Alongside other platform teams, the RWE Oncology Team Lead will build collaborative connections to provide superior support for the development and execution of oncology RWE studies in priority markets.

The RWE Oncology Lead will be responsible for cultivating and managing teams that work closely with CMAO and POD oncology teams to thoroughly understand their strategies, facilitate integrated evidence plans, develop tactics, and design and implement strategically focused studies.

They will also work with teams to gain insights into the advantages and limitations of various real-world data sources through cross-functional collaboration with the Platforms and Partnerships team.

This role oversees a team of approximately 15 senior directors through manager-level RWE scientists, epidemiologists, clinical scientists, and clinical operations personnel.

The leadership team will act as the primary contacts for RWE oncology requirements as outlined in Integrated Evidence Plans and GMAT governance.

To achieve this, the head will establish KPIs and success metrics with each therapeutic area-aligned team and other Platform colleagues.

They will guide their teams to operate within highly matrixed cross-functional environments to design study concepts, draft robust protocols, leverage RWD knowledge, incorporate standard care and endpoints, ensure high-quality statistical analysis plans (SAPs), and deliver RWE for interpretation and dissemination.

The lead will also direct their teams to swiftly communicate successes, publications, speaking engagements, and lessons learned to the EvGen Impact Translation lead.

This leader will collaborate with other senior leaders and category-aligned RWE teams, including RWE Primary and Specialty Care, RWE Clinical Affairs & Clinical Operations, Study Quality Control & Compliance, and RWE Platforms & Partnerships.

Externally, the RWE Oncology Lead will engage with leaders from Biostatistics & Data Management, Global Regulatory Affairs, Clinical Pharmacology/Pharmacometrics, HEOR, Legal/Compliance, and others to meet research and business objectives.

They will serve as an external representative for study execution, providing expert knowledge in epidemiology, statistics, methodology, and execution excellence.

Additionally, they will act as a trusted expert with study/analytical key opinion leaders (KOLs), key regulatory agencies, health technology assessments (HTAs), payers, and other stakeholders.

The RWE Oncology Lead will collaborate with cross-functional partners and the integrated evidence planning team to create integrated evidence plans, determine optimal methodological approaches and study designs, assess project feasibility, select appropriate real-world databases, and ultimately deliver all in-scope evidence.

They will monitor team performance and report metrics, challenges, and opportunities back to the CMAO RWE, Patient Advocacy, and External Collaborations.


KEY RESPONSIBILITIES:

Identify innovative opportunities and new method developments while driving best practices for real-world evidence generation internally and externally.

Create and implement a framework for evaluating the success and impact of the RWE platform.

Monitor and report on study progress and KPIs for the team.

Lead a team of senior directors and individual contributors responsible for strategic planning, designing, and executing high-quality, strategy-focused studies.

Establish operational and resource models for the team in collaboration with the RWE leadership.

Direct the leadership team towards technical and operational excellence, serving as a senior leader for Oncology RWE, RWD, RWI generation, patient engagement, and communication challenges.

Foster a culture of continuous learning and objective measurement activities for comprehensive evidence generation.

Ensure accountability for the management and development of a diverse talent pipeline.

Act as a leading internal RWE scientific expert and external representative of Pfizer at global technical conferences and initiatives.

Advocate for the scientific and clinical value of Pfizer's pipeline and products, promoting transformative policy changes to enhance global regulatory agency, patient, and provider confidence in RWE.


MINIMUM QUALIFICATIONS:

Advanced degree, including MD, PhD, or equivalent qualifications.

At least 20 years of hands-on experience leading teams in multiple disciplines such as epidemiology, pharmacoepidemiology, database analysis, statistics, study design, and clinical characteristics.

Familiarity with product development is preferred, though prior pharmaceutical experience is not mandatory.

Experience in leading and managing organizational structures with significant supervisory and budgetary responsibilities.

High energy, enthusiasm, and motivation for scientific discovery and team development.

Extensive cross-functional leadership experience, including collaboration with diverse cultures.

Demonstrated ability to create and articulate global strategies and supervise highly skilled professionals.

Excellent public speaking and communication skills, evidenced by presentations at conferences and participation in committees.

Proven track record of delivering high-quality results within established timelines.

Able to prioritize and manage complex projects to meet milestones within budget.

Ability to discuss scientific aspects of drug development and navigate commercial and regulatory discussions.

Capable of leading teams through ambiguity while inspiring them to follow a shared vision.


PREFERRED QUALIFICATIONS:

Advanced degree in Medicine, Pharmacy, Epidemiology, or a related healthcare field.

Experience executing major late-phase development or post-approval pharmaceutical product programs.

A blend of non-pharmaceutical and pharmaceutical experience in relevant areas for target assets.

Experience working with key regulatory agencies regarding pharmaceutical indications and labeling issues.

Proficiency in multiple languages.

Experience overseeing studies in diverse global settings.


OTHER DETAILS:

This position may require travel of 20-50%, depending on organizational needs.

Pfizer is committed to equal opportunity in employment and complies with all applicable laws governing nondiscrimination.