Director - Quality & Manufacturing Development

Director, Patient Advocacy & External Partnerships
Pfizer
Employment Type: Full Time
Biotechnology and Pharmaceutical, Government and Policy, Healthcare, Other, Healthcare, Practitioner and Technician, Legal, Manufacturing and Production, Sales, Science, Quality Control, Research & Development, Medical, Writing/Authoring, Energy / Utilities
Director, Patient Advocacy & External Partnerships
**The Platform:** The Chief Medical Affairs Office's Real World Evidence (RWE) Platform is responsible for establishing global scientific leadership and stature as well as building public & patient trust 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. 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 RWE; 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; 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.
**Reporting to the Head of Patient Advocacy & External Partnerships, this role is critical for the RWE Platform to ensure that the voice of the patient is at the center of our work. They will coordinate closely with RWE Strategic Planning & Business Operations Leaders, as well as those from other RWE teams and cross-functional partners as assigned, to execute on a vision for inclusion of patients / patient advocates in key strategic tactics as part of a comprehensive integrated evidence plans & RWE generation priorities. Any operating model must take into account the need to scale over time and the inclusion of voices from different countries and regions. They will also seek to engage with patients and patient advocacy groups to garner their support for evidence interpretation and dissemination, giving their voice and positions to the appropriate Pfizer governance cross-functional team(s).
They will regularly perform literature reviews and landscape assessments as directed for novel real world databases, registries and other relevant technologies stemming from patient advocacy, federal government, or other sources, and share these back with RWE leadership and other stakeholders. This role will also serve as a trusted expert for incorporating the voice of the patient into research and business evidence with key regulatory agencies (e.g., Clinical communities and professional societies who maintain evidence-based guidelines, FDA in the US, EMA in Europe, MHRA in the UK, PDMA in Japan, CDE in China), HTAs/Payers, and other stakeholders as needed. Finally they will help define and track success metrics and relevant KPIs as directed by the Head of Patient Advocacy and External Partnerships, then rapidly communicate their successes, publications, external speaking engagements, and lessons learned to the RWE Impact Translation lead.
**Under supervision from their supervisor, develop execution plans to realize our vision for patient-centric RWE and inclusion of the patient voice in global, regional and local level for priority markets
+ Proactively partner with RWE Strategists, RWE Science & Epidemiology Leads, Clinical Scientists, Platforms & Partnerships and other colleagues to maximize inclusion of the patient voice where appropriate
+ Perform literature reviews and landscape assessments of novel real world datasets, registries and related deliverables from patient advocacy groups
+ Design studies to deliver cutting-edge research & lead external facing projects that expand Pfizer's leadership in Patient & Public Involvement and Engagement (PPIE) from single market excellence to span across all 16 key "anchor" markets
+ Provide expert consultation as directed to inform patient advocacy groups' RWE-related activities by sharing best practices, approaches and applicable common data models / data standards, where appropriate
+ Create executive summaries of opportunities from the literature, white papers, conferences and stakeholder events to bring back to the Platform and present in risk/benefits, required investment, and anticipated impact for our patients
+ Supports the Head in building upon a team culture of continuous learning & objective measurements activities for end-to-end evidence generation
**Advanced degree, including MD, PhD or equivalent qualifications or demonstrated successful professional experience.
+ The incumbent must have at least 10 years' experience hands-on expertise with a BS/BA, 8 years' experience with an MBA/MS, 6 years' experience with a PhD/Pharm D. or 3 years' experience with an MD with multiple of the following disciplines and approaches: patient care, standard of care across countries, patient advocacy groups, relevant policy, standards development organizations & applicable global data standards, situational leadership, site-based epidemiology, pharmacoepidemiology, statistics, study design, clinical characteristics, pharmaceutical safety, pathophysiology, retrospective RWD sources, and RWE-adjacent enabling technologies and approaches. A high degree of energy, enthusiasm and motivation for scientific discoveries
+ Leadership in a related scientific field, e.g., Global recognition as a scientific leader with e.g., 10+ scientific publications in peer-reviewed journals and conference proceedings in areas relevant for the target assets
+ experience working in US healthcare and with US Patient Advocacy groups or Patient Involvement and Engagement initiatives highly preferred
+ Demonstration of a wide network of peers in relevant disciplines (e.g., Leading the scientific and patient-centricity narrative with patients, patient groups and relevant external partners, as well as policy makers and providers as assigned by the Head of Patient Advocacy & External Collaborations
+ Demonstrated strong work ethic, and proven track record of delivering high quality within timelines.
**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
+ NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS**
Travel of 5-10%, depending on budgets, organizational needs, and any other relevant restrictions
**In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 20.0% 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. Pfizer compensation structures and benefit packages are aligned based on the location of hire. Relocation assistance may be available based on business needs and/or eligibility.
**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. 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.
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