Head of Oncology RWE Strategic Planning

Key Skills

Biostatistics, Design, Leadership Skill, Machine learning techniques, Oncology, Planning and organization, SLA, Statistics, Teamwork

Job Description

The Chief Medical Affairs Office’s Evidence Generation (EvGen) 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, international developed market (IDM) and emerging markets (EM) 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.

RWE, other patient-centric evidence, and RWI will be generated by the Platform for all global, prioritized IDM and prioritized EM 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: This role is for a unique leader who is able to direct and manage teams and lead through influence across a wide variety of business verticals across the lifecycle, understand highly technical WE/Epidemiology/Statistical/Advanced Methods opportunities and communicate them to diverse audiences who lack expertise, create business plans and proposals, exhibit a high social IQ, and has deep experience with demonstrated history of success with global regulatory authorities, HTAs, and other stakeholders.

It plays a critical role in the development of a comprehensive RWE strategy, tactical plans, and projects that meet research and business needs at the global, regional and local level for priority markets worldwide. They are key members of multiple layers of lifecycle and franchise or asset governance. They will also provide matrixed leadership and oversight of all projects executed by Oncology RWE Science & Epidemiology and Clinical Affairs & Operations teams, restructuring priorities as needed based on shifting priorities for R&D and the business. To carry out this work, they will be responsible for maintaining relationships with Oncology leadership (CxO, SVP and VP) from research, biopharma business and business innovation. Finally, they will be an internationally-renowned external face of Pfizer, representing the organization and team at global industry events, conferences and symposia.

The position will lead a rapidly growing team through DP3, operational plans and the Seagen Integration of 5 individual contributor Sr Director Oncology RWE Strategic Planning franchise leaders dedicated to supporting the development of an Integrated Evidence Plan beginning on or before POC through LOE, evolving that plan & incorporating into relevant governance documents, accelerating and strengthening access for patients in priority markets worldwide with Global & Country Access and Value colleagues, ensuring that work by execution arms (RWE Science & Epidemiology for retrospective studies and Clinical Affairs for site-based prospective studies) is consistent with strategy, and other duties. They will also lead cross-functional teams to consider myriad scenarios to proactively create alternative solutions based on headwinds and tailwinds. The Head serve as single point of contact for all RWE planning readiness, strategic planning & tactical priority needs, incorporation of ex-US country CMAO colleagues’ feedback into strategies and tactics wherever applicable, ensuring that RWE Strategies equate to high ROI and actionable project plans, and identifies novel innovation & efficiency opportunities. They will serve as or assign duties as the Platform representative on all applicable Oncology franchise and asset governance committees (Global Product Teams, SLAC, Medical Strategy Teams, Integrated Value and Access Teams, etc.) across the lifecycle.

They will be responsible for directing their team to co-create integrated evidence plans early in the product lifecycle with cross-functional partners, ensuring that the IEP is appropriately documented in digital systems, maintaining and versioning those IEPs, calculating the ROI for each RWE project, providing guidance to execution teams on 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 their leader.

They also will be responsible for ensuring their direct reports oversee the work of execution teams to generate high quality and compliant evidence using retrospective RWD sources, technology-based direct-from-patient approaches for observational, site-based observational trials, and hybrid interventional / RWE trials. To do so, they will work in highly-matrixed cross-functional leadership teams and oversee study concepts, protocols to ensure robust designs, leverage knowledge of RWD and data standards, incorporate knowledge of standard of care and endpoints for given categories, and help interpret and disseminate results as part of cross-functional teams. The lead will also direct their reports and “dotted line reporting” Oncology-dedicated execution team members to rapidly communicate successes, publications, external speaking engagements, and lessons learned to the EvGen Impact Translation lead.

This leader will also work across other Platform capabilities’ senior leaders and in collaborations with Platform peers including VPs and other Heads of Evidence Strategic Planning, Head of Business Operations, the Oncology RWE Science & Epidemiology team lead, Oncology team leads for RWE Clinical Affairs & Clinical Operations, Study Quality & Compliance, and RWE Platforms & Partnerships.

Outside of the Platform, the colleague will work with senior executive leaders from R&D, Portfolio Management, CMAOs, Medical Affairs Strategy, Biostatistics & Data Management, Global Regulatory Affairs, Clinical Pharmacology / Pharmacometrics, Market Access, Business Assessment & Development, Digital, Legal/Compliance, and others to achieve research and business objectives.

They will also serve as an external face for 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.

ROLE RESPONSIBILITIES

• Independently creates a vision, gain cross-functional CxO/SVP/VP-level endorsement, and drive it to evidence delivery for patient-centric early integrated evidence generation for the Pfizer enterprise at a global, regional and local level
• Ensures that the Platform at-large is delivering on the vision and ambition across teams, proactively identify barriers, and remove them for their team or cross-functional partners
• Establishes team culture and ways of working, supporting their direct reports and other mentees through change and growth opportunities
• Identifies, monitors and reports on KPIs for the Oncology x-functional EvGen RWE teams to senior leaders across the organization
• Direct, lead and grow a team of individual contributor Oncology Sr Directors to establish category-level RWE strategies, scenario and tactical plans, operating models and quality control procedures in accordance with relevant Pfizer SOPs and industry best practices
• Leads through “dotted line reporting” without HR supervisorial responsibilities at team of ~30 Oncology-dedicated RWE Science & Epidemiology and ~15 Oncology-dedicated Clinical Affairs execution colleagues
• Partners with VP Head of Partnerships & Platforms and VP, Head of Quality and Compliance to drive both innovative data and technology opportunities, as well as ensuring full compliance with Pfizer SOPs/policies, global regulatory authority (GRA) guidances and policies, and HTA/payer/federal government mandates
• Serves as an internationally-recognized face to GRAs, HTAs/payers and federal government agencies as an industry-leading expert in RWE
• Responsible for oversight, quality and innovation of all prioritized global, regional and local studies
• Drives technical and operational excellence for their category
• Oversees their team’s effective collaboration with RWE Science & Epidemiology, Category R&D / CMAO / GAV leaders, RWE Platforms and Partnerships colleagues, Clinical Scientists, Biostatistics, Statistical Programming and Digital to identify and fill RWD gaps using fit-for-purpose sources worldwide, incorporate advanced analytical and machine learning approaches, and scale innovations across category teams
• Directs and supervises team to ensure continuous learning & objective measurements for end-to-end evidence generation ROI and impacts
• Partners with Head of RWE EvGen Innovation and Head of Platforms & Partnerships to scale innovation opportunities across assets, franchises and categories
• Directs their team to set standards for cross-functional team-endorsed cohort definitions and business rules in collaboration with SMEs and RWE Science & Epidemiology members, versioning those rules to meet various use cases & ensuring that teams systematically incorporate these rules into their work for consistency across the lifecycle
• Proactively apprise senior Oncology leadership (CxO, SVP) on strategies, priorities, study plans and opportunities, engaging in spirited scientific discourse & leading discussions when disciplined trade-off decisions must be made
• Serve as a leading internal Oncology RWE scientific expert and external face of Pfizer at global technical conferences, events and initiatives
• Builds upon existing globally-recognized leadership thru scientific publications and white papers
• Advocates and champions 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.

REQUIRED EXPERIENCE, TRAINING AND EDUCATION

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

• Advanced degree required, including MD, PhD.
• The incumbent must have at least 8 years’ experience with PhD or 5 years' experience with MD, 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. Candidates who have only outsourced study design and execution need not apply.
• Direct experience as part of product development cross-functional teams
• A high degree of energy, enthusiasm and motivation for scientific discoveries
• Strong situational leadership skills & the ability to lead through influence
• 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.
• Global recognition as a scientific leader with e.g., 15+ scientific publications in peer-reviewed journals and conference proceedings in areas relevant for the target assets
• Demonstration of a wide network of peers in a relevant disciplines (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.

PREFERRED QUALIFICATIONS

• Practicing clinical oncologist, oncology-specialist pathologist or surgical oncologist
• 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)

Other Job Details:

• Last Date to Apply for Job: February 16th, 2024
• Travel of 10-30%, depending on budgets, organizational needs, and any other relevant restrictions
• Not eligible for relocation package

LI-PFE

The annual base salary for this position ranges from $226,200.00 to $377,000.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 25.0% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.

Relocation assistance may be available based on business needs and/or eligibility.

Sunshine Act

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.