Published
February 12, 2020
Location
New York, United States of America
Job Type
Work Setting
Remote / Home-based

Description

The Global Medical Epidemiology (GME) & Big Data Shared Services group is an internal, client-facing advisory services function that works closely with RU/BU/Medical Affairs/Functional Areas to thoroughly understand the regulatory/business priorities, opportunities and challenges as well as the EPI/RWE strategy and tactics and utilize Big Data Analytics shared services capabilities to address business opportunities proactively. They will work with each portfolio/functional team to develop a global medical epidemiology (EPI) / real world data (RWE) strategy that is specific to the portfolio. They will also design and execute advanced analytic studies in collaboration with the Safety Surveillance Research (SSR) team and external partners. More specifically, they will:

  • Be aligned to a specific business unit/therapeutic area and become a strategic partner for product development, launch, and extensions
  • Identify strategic opportunities and innovative solutions and develop business cases to leverage EPI/RWE;
  • Partner closely with SSR, RWDnA, HEOR, Market Access, Medical Affairs, Global Clinical Development, Global Product Development, etc. to examine EPI/RWE needs;
  • Immerse in cross-functional asset team discussions aligned with priorities; and
  • Lead educational efforts with Pfizer’ global functions on appropriate EPI/RWE use to meet their business needs —scoping projects and working with other members in the EPI/RWE function to enable appropriate project execution.

The ideal candidate should have extensive experience in epidemiology, real world evidence analytics and/or health informatics, and have capability to design alternative pathways and to work collaboratively with other strategists to source key epidemiological data, gain acceptability for methods, and build analyses for benefit-risk justifications, development and other regulatory needs for the business units’ / research units’ portfolios.

Additionally, this role will provide support to the Internal Medicine and the Hospital business unit, provide direct line management to the flex pool of 2-5 operational team members/support, and mentor/lead the other GME Shared Services / CoEs.

This role requires someone with strong strategic thinking, leadership, communication and people management skills. The position will report directly to the Vice President, Global Medical Epidemiology and Big Data, based in NYHQ,

ROLE RESPONSIBILITIES

CLIENT/REGULATOR RELATIONSHIP & BUSINESS DEVELOPMENT

  • Responsible for the development and implementation of a RU/BU/Medical Affairs Portfolio level EPI/RWE strategic plan and governance structure
  • Build effective working relationships with RU/BU Portfolio leads and medical affairs team leads to ensure that EPI/RWE strategy and ensure plan fully reflect stakeholder requirements
  • Builds relationship, align, and negotiate with portfolio teams, RU/BU/Medical Affairs, regional, and corporate leaders and internal/external stakeholders for agreement on decisions, justifications, alternative pathways, policies, and processes
  • Partners with development and product team leads to oversee budget for epidemiology studies, data acquisition, tech development, or academic/industry collaborations
  • Manages interface with study management, operations, statistics, clinical, and finance
  • Established credibility / trust and advises/pilots with Regulators / Health Authorities to negotiate standardizable solutions by development problem type (small pop, rare signal, break-through) and achieve success by defending pathways and product benefit/risk
  • Aligns and manages stakeholders on pathway and customizes overall prospective strategy for portfolio
  • Ensures awareness by appropriate functional groups of deliverables and timelines (e.g., QA/QC, Regulatory, QPPV)
  • Provide expert consultation on all aspects of internal EPI/RWE database studies/analyses including objectives, study design, data source identification, protocol development, statistical analysis, and/or interpretation
  • Forms strong partnerships with business units, medical affairs, market access, and HEOR teams in understanding EPI/RWE analysis needs and priorities, and comes up with plans to execute EPI/RWE projects based on those needs
  • Acts as a Liaison for the Global Medical Epidemiology (GME) & Big Data Shared Services group across Pfizer
  • Contribute to the development and implementation of an enterprise GME strategy at Pfizer

MANAGEMENT & MENTORSHIP

  • Lead, mentor, support, and provide direct line management to the flex pool of 2-5 operational resources or contractors
  • Lead, mentor, support, and provide direction to designers and strategists about accountable area of expertise

EPI/RWE EXPERTISE

  • Proposes, develops and leads/oversees key cross-functional strategic initiatives
  • Determines and aligns decision-makers on portfolio-wide core study design needs, strategy, and opportunities for alternative pathways already negotiated with regulators
  • Lead teams across the project lifecycle from requirements gathering, data acquisition and preparation, hypothesis generation, ideation, coding, testing, and deployment of data science product
  • Develop a deep understanding of the evidence needs and ensure delivery of EPI/RWE programs that are responsive and strongly supportive of the value evidence strategy
  • Ensure high quality, readily interpretable deliverables (e.g. data tables, graphs, charts, study reports) are generated from EPI/RWE studies/analyses
  • As relevant to specialization, understand epidemiologic needs for key disease areas or ensure appropriate methods, analytics, or data sources to be utilized and responsible for ensuring inspection readiness and business/regulatory compliance
  • GME Strategist: Leads knowledge center and operational continuity for disease-area focused content or epidemiologic data/methods/analyses, issues and represents these to customers, collaborators, and external parties (regulatory authorities, opinion leaders, academia, investigators, etc.)

TEAM MANAGEMENT

  • Reviews and approves EPI/RWE deliverables for development and product teams using established systems within Epidemiology for maintaining quality (i.e., ETRC process)
  • Responsible for resource allocation decisions and sharing resource for support across the portfolio
  • Reviews and approves EPI/RWE deliverables for development and product teams using established systems within EPI/RWE for maintaining quality (i.e., ETRC process)
  • Advises, manages, and trains team members to deliver projects on time, with quality, efficiently, and effectively

EDUCATION & COMMUNICATION
INTERNAL

  • Contribute to the continuing education of relevant line functions on the use of EPI/RWE
  • Develops and implements strategic communication plan to educate Pfizer stakeholders of the value, opportunities, data, methods, analytics, and processes to implement alternative pathways and studies
  • Ensures awareness and adoption of GME & Big Data CoE shared services capabilities by appropriate functional groups within Pfizer

EXTERNAL

  • Influences the external environment as a public spokesperson and demonstrated leader (e.g., leadership and membership in PhRMA, ISPE or other scientific bodies, scientific presentations and publications)
  • Publication and presentation of EPI/RWE projects at internal meetings, and external industry conference/workshops
  • Develop effective relationships with external thought leaders in EPI/RWD/RWE, comparative effectiveness research, health informatics, and data sciences so as to maintain an extensive understanding of external environment, to create opportunities for engagement, and to establish Pfizer as a leader in the field.

BASIC QUALIFICATIONS

  • PhD, MD, or PharmD and 7+ years of experience in Data Science, Bioinformatics, Clinical Science, Epidemiology, Quantitative Public Health discipline, or related discipline
  • Strong preference for 5 or more years’ experience in the pharmaceutical industry; extensive track record interacting with R&D and commercial organizations in pharmaceutical industry
  • Extensive track record and experience in observational and real-world data studies and applying epidemiologic methods to clinical research
  • Demonstrated depth of understanding of observational research methods, HTA, comparative effectiveness research, health care and data science trends, and ability to leverage health outcomes and data science expertise to meet evolving business needs
  • Evidence of technical expertise of applying EPI/RWE evidence and insights at the therapy/product level
  • Understanding client challenges and soliciting support for new opportunities to build project portfolio
  • Interpersonal skills to seamlessly interact on both business and scientific issues along with negotiation and facilitation skills to align group decisions
  • Experienced in managing meetings / projects / team members
  • Creative skills in designing alternative approaches, new solutions, or innovations
  • Ability to identify common operational trends and to standardize and optimize processes for ease of implementation
  • Extensive expertise in EPI/RWE to advise, on disease areas, data, technology, and risk management strategies to development projects and marketed products
  • Previous successful pilots with alternative rationale
  • Ability to explain strengths and limitations of EPI/RWE datasets — such as electronic health records, claims, clinical data registries, patient generated health data, and other health data sources — in context of designing EPI/RWE data study designs

PREFERRED QUALIFICATIONS

  • Established credibility / trust with Regulators
  • Previous successful pilots with alternative rationale
  • Proven success defending product with regulators
  • Extensive expertise in EPI/RWE/Big Data to advise PFE
  • Stakeholder negotiation/defense optimizer
  • SME Operational Continuity
  • Respected advisor / trusted aligner across stakeholders
  • Excels in leading multi-functional teams to customize portfolio-wide evidence-based strategies
  • Extensive expertise aligning decision-makers in alternative directions prospectively
  • Experienced leader with demonstrated ability to build effective teams and develop talent
  • Able to motivate and channel energy of others toward a clear purpose
  • Demonstrated ability to develop and maintain strong relationships with external customers and experts
  • Well-developed business acumen
  • Demonstrated customer focus
  • Excellent matrix, interpersonal and influencing and decision-making skills
  • Financial management experience
  • Experience in leading and managing change, including a track record of flexible, out-of-the-box thinking and responding effectively to rapidly changing requirements
  • Excellent verbal and written communications skills
  • Enlists others to align objectives with those of the organization
  • Demonstrates evidence of strategic thinking and is able to effectively communicate the impact of proposed plans and actions
  • Strong desire to reach challenging goals and continuously improve
  • Works tenaciously through difficulties to achieve best results

Other Job Details:

  • Additional Location Information: New York, NY (Headquarters) is the preferred location but also open to consider US remote based.
  • Eligible for Relocation Package
  • Eligible for Employee Referral Bonus
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