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 lead. This 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 report metrics, challenges and opportunities back to the CMAO RWE, Patient Advocacy and External Collaborations. 

ROLE RESPONSIBILITIES 

• Identify opportunities for innovation and new methods development and participate in driving forward best practices for real world evidence generation internally and externally. 

• Create and implement a framework for measuring the success and impact of the RWE platform 

• Identifies, monitors and reports on study progress and KPIs for the team 

• Directs and leads a team of Sr Director team leaders and Sr Director through Manager-level individual contributor RWE colleagues responsible for driving strategic planning, designing and executing high-quality, strategy-focused studies. 

• Establishes operating and resourcing model for their team in collaboration with the RWE leadership team. 

• Directs leadership team in technical and operational excellence and serves as a senior leader to their organization for Oncology RWE, RWD, RWI generation, patient engagement and communication challenges 

• Leads team to build upon a culture of continuous learning & objective measurements activities for end-to-end evidence generation. 

• Holds their team accountable for management & development of a diverse talent pipeline 

• Serve as a leading internal RWE scientific expert and external face of Pfizer at global technical conferences, events and initiatives. Advocate and champion for the science and clinical value of Pfizer’s pipeline & products within the target asset classes and for transformative policy changes to increase global regulatory agency, patient and provider confidence in and acceptance of RWE. 

BASIC QUALIFICATIONS 

Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact. 

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

• The incumbent must have at least Bachelors + 20 years’ experience hands-on expertise and in leading teams with multiple of the following disciplines and approaches: site-based epidemiology, pharmacoepidemiology, database analysis, statistics, study design, basic science, clinical characteristics, pharmaceutical safety, pathophysiology, retrospective RWD sources, and RWE-adjacent enabling technologies and approaches; Masters/MPH and at least 18 years' experience; PHD/PharmD and at least 15+ years' experience; MD and at least 9+ years' experience.  

• Familiarity with product development; this does not require previous pharmaceutical experience, as work on new products (e.g., effectiveness studies) could be done through an academic appointment. 

• Experience having led and grown (staff and budget) at least one organizational structure with substantial supervisory & fiscal / budgetary responsibility 

• A high degree of energy, enthusiasm and motivation for scientific discoveries and developing a team 

• Significant cross-functional leadership/management experience including colleagues from different countries and cultures 

• Leadership in a related scientific field, e.g., in professional societies, government, international bodies, etc. 

• Demonstration of a wide network of peers in a relevant discipline (e.g., co-authors and participation on professional societies, technical working groups, committees, etc.) 

• Demonstrated ability to create and articulate global strategies, supervise & develop highly skilled and seasoned professionals, and to lead across diverse cultures and geographies through influence even in the absence of authority 

• Able to act independently as well as cross-functionally to achieve program goals 

• Excellence in speaking/communicating publicly as evidenced by presentations at congresses, participation on committees/working groups, etc. 

• Demonstrated strong work ethic, and proven track record of delivering high quality within timelines. 

• Able to set priorities and manage cross-functional teams and complex projects to deliver milestones according to set budgets. 

• Ability to discuss scientific aspects of drug development, also comfortable in discussing commercial and regulatory issues. 

• Able to lead teams through ambiguity and have them excited to follow a vision 

PREFERRED QUALIFICATIONS 

• Advanced degree in Medicine, Pharmacy, Epidemiology or related healthcare field  

• Successfully executed a major late phase development or post-approval pharmaceutical product program. 

• A blend of non-pharmaceutical (academia, government, NGO) and pharmaceutical experience in relevant areas for target assets; pharmaceutical experience could be through partnerships or engagement in sponsored trials/studies rather than through employment 

• Experience working with key regulatory agencies (FDA, EMA, MHRA, etc.) regarding pharmaceutical indication and/or labeling issues. 

• Multiple languages 

• Experiences overseeing or implementing studies in multiple settings globally (e.g., both developed and developing countries) 

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS  

Travel of 20-50%, depending on budgets, organizational needs, and any other relevant restrictions 

OTHER JOB DETAILS:

Last Date to Apply for Job: August 23, 2024

Additional Location Information: New York, NY; Collegeville, PA; Cambridge, MA; Groton, CT; Bothell, WA, Lake Forest, IL; La Jolla, CA; Tampa, FL; San Francisco, CA; Memphis, TN; North America - Any Pfizer site; Europe - Any Pfizer site.