Pfizer VP, Head of Inflammation & Immunology and Internal Medicine Enterprise RWE, Evidence Generation Platform in Baton Rouge, Louisiana
This position will assume a key leadership role within the Pfizer organization, serving as the Enterprise RWE Head for Inflammation & Immunology (I&I) and Internal Medicine (IM) Evidence Generation. This position will be housed in the newly formed Evidence Generation Platform, which is responsible for establishing scientific global leadership in RWE, clinical and pharmacoepidemiology, biomedical and health informatics and other disciplines. The successful candidate will advance Pfizer's stature through the generation of integrated, end-to-end observational real-world evidence serving all therapeutic areas from molecule to marketplace. The Platform will combine two formerly disparate Pfizer functions to:
enhance Pfizer's ability to determine unmet medical needs;
support current 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 PHI, 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.
Activities will focus on informing decisions related to Pfizer products throughout the lifecycle, such as decisions to invest, clinical development program trial designs, recommendations by expert societies, provider use, and uptake. The successful candidate will have direct responsibility and accountability for development of medical/clinical and lifecycle evidence development strategies consistent with candidate/asset strategies from accountable internal R&D, Medical Affairs and Access stakeholders.
Specifically, this role will support the research and development pipeline across two functions (early and late development), Clinical Development & Operations, Commercial Strategy, Business Assessment & Development, Global Medical Affairs, Market Access / Health Economics and Outcomes Research (HEOR), and other functions' needs for priority candidates & products in I&I and IM. The inter-disciplinary team will collaborate closely with colleagues across the enterprise such as late development's RWE and other biostatistics experts, statistical programmers, data scientists in Digital and other teams, and myriad others.
This will be achieved through a combinatorial approach of cutting edge, field-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), generation of robust real world insights and evidence, and supplementation of randomized, controlled trials with RWE through hybrid trial designs and tokenization.
The Head will lead I&I- and IM disease-dedicated inter-disciplinary teams of clinical epidemiologists, informaticians, economists and other technical experts to carry out hands-on in silico science. The position initially will have supervisory responsibility for 10 colleagues and 3 affiliate contractors within the two sub-teams, with an expectation to develop and grow the teams to meet the needs of Pfizer, primarily by demonstrating the value of evidence generation outcomes and thus justifying an increasingly substantial budget and staff. Consequently, this is a position for a dynamic and motivated person who enjoys the challenge and excitement of building a team, identifying fresh talent and advancing their careers.
The Head will also work closely with their counterparts on the Enterprise RWE Leadership Team, including leaders of other therapeutic area-aligned RWE teams, VP and Head of Evidence Generation Platforms & Partnerships, VP and Head of Phase IV Biostatistics and RW Data Science, and Head of GLocal RWE Network. Additional support will come from internal colleagues in the Evidence Generation Implementation team, which will provide project management and diverse operations support, and enterprise collaborators from Digital and other teams. External collaborators may come from academia, government, CROs, and private industry.
The position will integrate within various groups internal to Pfizer such as Clinical Research and Development, Regulatory, Public Policy, Health Economics and Outcomes Research, Emerging Markets, Country level medical staff, commercial, business development; and other professionals within the 2 target asset groups and externally with KOLs, medical society members, key regulatory agencies (e.g., FDA in the US, EMA in Europe, MHRA in the UK, PDMA in Japan, CDE in China), and key scientists globally that can implement high priority global studies.
Since a key aspect of this role is to generate and communicate the science and clinical value for the target assets including overseeing the design and implementation of a diverse collection of studies the incumbent should have expertise or familiarity with field-based epidemiology, database analysis, statistics, study design, basic science, clinical characteristics, pharmaceutical safety, and pathophysiology, across the lifespan.
In summary, this is a scientific and leadership position and will require someone with a love of science and answering critical questions to information patients' health, and who has the enthusiasm and energy to build a team to achieve this goal.
The VP and Head of Enterprise RWE for I&I and IM Evidence Generation is responsible and accountable for creating strategies and approaches for complex, multifaceted challenges across the asset lifecycle to accelerate our development and access timelines, generating insights and evidence to influence and shape senior executive decisions and table stakes multi-billion dollar investments related to Pfizer products in two highly innovative therapeutic areas, and grow and defend the current product portfolio's market share. This work will require agility and the ability to rapidly assess research and business issues & ensure appropriate solutions are deployed to resolve them, as decisions will have significant impact to long-term enterprise objectives.
Proactively partners directly with the assigned TA's Chief Science, Chief Development, and Chief Medical Affairs Officers along with Executive Director/VP/SVP level leaders in other TA-aligned teams to serve as a key strategic advisor in cross-functional strategy development & operations
Create a vision for I&I and IM teams, respectively, to develop and implement strategy & tactics for a team of doctoral and master's level professionals that will lead scientific affairs activities globally for end-to-end evidence generation. Holds their team accountable for management & development of a diverse talent pipeline.
Serve as the leading internal and external scientific expert, advocate and champion for the science and clinical value of Pfizer's pipeline & products within the target asset classes, developing & implementing communication strategies for the enterprise and for ushering in transformative policy changes to increase global regulatory agency, patient and provider confidence in and acceptance of RWE.
Accountable for internal Pfizer strategy for obtaining recommendations and informing clinical decisions for pipeline candidates & products within the target asset classes.
Responsible for the development and execution of a scientific RWE, RWI and RWD differentiation strategy for products with strong competitors in key areas.
Create and communicate a strategy for I&I and IM partnerships within Innovation Hub teams led by the sister Evidence Generation Platform's Enterprise RWE Platforms & Partnerships group.
Lead/oversee and provide technical expertise for all epidemiologic, observational, low-interventional and hybrid RWE/clinical trial studies to support pre-licensure clinical development programs for the target assets
Lead/oversee and provide technical expertise for all epidemiologic and observational studies to support regulatory goals (label enhancement, post-authorization commitments) for the target assets
Lead or collaborate on studies to define novel pathways to licensure
Lead/oversee and provide technical expertise for all studies informing product effectiveness, epidemiology, and clinical outcomes in the post-licensure space to support recommendations and uptake including:
Field based (hospital/outpatient) surveillance studies
Effectiveness studies in specific groups (immunocompromised, at-risk, older individuals, preterm infants, pregnant women) using surveillance projects and real-world database
Full clinical value of products by assessing impact on quality of life, long-term outcomes (disease exacerbations, death), etc.
Cutting edge studies (e.g., omics) to determine biologic bases for epidemiologic and effectiveness data
Laboratory / next-generation sequencing / precision medicine science to better define under-ascertainment of disease burden and to improve existing technologies
Design novel scientific strategies and methods to improve/inform recommendations and product labels such as using real world effectiveness for label indications
Participates on core team and program team meetings for clinical development programs for target assets
Lead/supervise global communication activities for the target assets (e.g., develop internal Pfizer scientific RW positions, engage KOLs in advisory boards & mock society/regulatory meetings, etc)
Improve Pfizer processes through active engagement in governance, contracting, and compliance
Ensure clear cross-functional goals are established & agreed to by working collaboratively within Pfizer with other members of the Evidence Generation team, regulatory, commercial, health economics and outcomes research, public policy, GCP, business development, and others.
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.
Demonstrated expertise in at least one of the target areas (I&I or IM)
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.
At least 15 years of experience in implementing or overseeing a wide variety of observational/field-based studies including field-based epidemiology, efficacy/effectiveness/impact, risk factors, immunology, pathophysiology, Inflammation, precision medicine, metabolic disease, cardiovascular disease or other relevant area
Experience having led and grown (staff and budget) at least one organizational structure with substantial supervisory (at least 10 people with responsibility for hiring) & fiscal / budgetary responsibility
A high degree of energy, enthusiasm and motivation for scientific discoveries and building a new team
Significant cross-functional leadership/management experience.
Leadership in a related scientific field, e.g., in professional societies, government, international bodies, etc.
Global recognition as a scientific leader with e.g., 50 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 area for target assets (e.g., co-authors and participation on professional societies, technical working groups, committees, etc.)
Academic credibility to be widely recognized as a global expert in at least one of the asset areas
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 review, evaluate, interpret and present complex data; understand the emerging safety and efficacy profile of pharmaceutical products.
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.
Experiences overseeing or implementing studies in multiple settings globally (e.g., both developed and developing countries)
While this position is for a leader, a past history of experience with protocol development, study implementation, data analysis and statistics would be helpful.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
- Travel of 20-25%, depending on budgets and COVID restrictions
Other Job Details:
Last Date to Apply for Job: March 31, 2023
Additional Location Information: US Remote or US Any Pfizer Site
Eligible for Relocation Package: No
Eligible for employee referral bonus
The annual base salary for this position ranges from $254,400.00 to $424,100.00. In addition, this position offers an annual bonus with a target of 30.0% of the base salary and eligibility to participate in our share based long term incentive program. Benefits offered include a retirement savings plan, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans. Salary range does not apply to the Tampa, FL location.
Relocation assistance may be available based on business needs and/or eligibility.
Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.
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.
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