DirecciónROLE 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, 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.
RWE, other patient-centric evidence, and RWI will be generated by the Platform for all global, prioritized international 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 plays a critical role in the development of a comprehensive RWE strategy, tactical plans, and projects that meet research and business needs. They also are key members of multiple layers of lifecycle and franchise or asset governance. They will also provide matrixed leadership and oversight of all gastrointestinal (GI) and lung cancer projects executed by RWE Science & Epidemiology and the Clinical Affairs & Operations teams, restructuring priorities as needed. To carry out this work, they will be responsible for maintaining relationships with key Oncology leadership from research, biopharma business and business innovation. Finally, they will be an external face of Pfizer, representing the organization and team at global industry events, conferences and symposia.
The position is for a seasoned individual contributor dedicated to supporting the development, digitization and evolution of an Integrated Evidence Plan, evolving that plan & incorporating into relevant governance documents, and other duties. They serve as single point of contact for GI & Lung cancer franchise IEP readiness, Strategic Planning & tactical priority needs valuations, cohesive linkages between strategies/scenario plans to tactics to project plans, and recommends novel innovation & efficiency opportunities. They will be the Platform representative on all applicable governance across the lifecycle. They will monitor their performance and report metrics, challenges and opportunities back to their Head of RWE Strategy Planning. Finally they will rapidly communicate successes, publications, external speaking engagements, and lessons learned to the RWE Impact Translation lead.
This leader will also work across RWE Platform capabilities' leaders including other RWE Strategic Planning colleagues, Business Operations Project Managers, IEP Success Leads, category-dedicated team leads for RWE Science & Epidemiology + RWE Clinical Affairs & Clinical Operations, Study Quality & Compliance, and RWE Platforms & Partnerships.
Outside of the Platform, the colleague will work with assigned franchise & asset leaders from R&D, Portfolio Management, CMAO, 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 a trusted expert as assigned 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 as needed.
ROLE RESPONSIBILITIES
- Support cross-functional teams to execute against a vision for patient-centric early integrated evidence generation for the Pfizer enterprise at a global, regional and local level and ensure that the Platform at-large is delivering on the vision and ambition across teams
- Identifies, monitors and reports on KPIs to the Head of RWE Strategic Planning for their category
- Establish franchise and/or asset-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 ~5-10 dedicated RWE Science & Epidemiology and Clinical Affairs execution colleagues
- Responsible for oversight, quality and innovation of all prioritized global, regional and local studies for assigned franchises & assets
- Collaborates with CMAO and RWE Platforms & 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
- Leads through influence to build upon a culture of continuous learning & objective measurements activities for end-to-end evidence generation.
- Identifies and scales innovation opportunities across categories / business units and franchises where applicable
- Ensures that appropriate standards for cross-functional team-endorsed cohort definitions and business rules are digitized and disseminated to appropriate teams, versioning those rules to meet various use cases & ensuring that teams systematically incorporate these rules into their work for consistency across the lifecycle
BASIC QUALIFICATIONS
- Advanced degree, including MD, PhD or equivalent qualifications.
- The incumbent must have at least 8 years' experience hands-on expertise with a PhD or 5 years' with an MD 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
- Ability to have spirited and direct scientific and operational discussions, seeking equitable decisions across all stakeholders
- 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
- 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 ~10%, depending on budgets, organizational needs, and any other relevant restrictions
ADDITIONAL DETAILS
- Last date to apply for Job: March 08, 2024.
The annual base salary for this position ranges from $191,300.00 to $318,800.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 22.5% 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.
EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States.
Market Access
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