Global Medical Strategy and Team Lead, Seasonal & Pipeline Viral Vaccines (non-MD)

The Global Medical Strategy and Team Lead Seasonal & Pipeline Viral Vaccines is responsible for designing and overseeing execution of the medical strategies leading to the licensure and public health implementation of seasonal vaccines in their portfolio. The portfolio includes COVID-19 vaccines combination vaccines that include COVID-19 pipeline vaccines administered on a seasonal basis and other viral pipeline vaccines. This includes developing the evidence generation strategy engaging external stakeholders and collaborating with Research Clinical Medical Evidence Generation and Commercial/Access cross-functional teams to optimize medical benefit and support vaccine recommendations globally.

The Global Medical Strategy and Team Lead Seasonal and Pipeline Viral Vaccines is expected to be an internally and externally recognized subject matter expert. They will be responsible for engaging the global medical community to identify the unmet medical need for vaccines in their portfolio. They will drive Pfizers presence and reputation within the global vaccine community and be a go to person for key opinion leaders (KOLs). They will actively build networks with KOLs in the infectious diseases and vaccinology field Vaccine Technical Committees (VTCs) healthcare policy makers and payers to obtain strategic input and establish research partnerships. They will present and/or represent Pfizer medical affairs at scientific meetings global policy meetings and VTC or regulatory meetings.

The Team Lead is expected to develop a highly productive team of medical affairs experts to deliver an aligned vaccine strategy. They will develop a multi-disciplinary research agenda that clearly defines the burden of disease due to pathogens in their portfolio; target age groups risk factors and outcomes; and includes vaccine effectiveness and other post-licensure evaluations to support competitive differentiation. They will develop vaccine target product profiles with cross-functional partners provide input on the clinical program needed to obtain recommendations / reimbursement and contribute to the regulatory strategy to optimize vaccine label. They will collaborate with commercial and market access teams to develop appropriate scientifically accurate marketing and access strategies and propose medical affairs tactics to support these activities.

This is a dynamic role that requires a firm understanding of the epidemiology of infectious diseases vaccine preclinical and clinical development post-licensure studies evidence dissemination and vaccine life cycle management. The leader is expected to objectively interpret technical and commercial information in order to optimize clinical development market access and lifecycle strategies.

ROLE RESPONSIBILITIES

• Identifies the unmet medical need for vaccines in their portfolio.
• Acts as key point of accountability for all scientific inquiries and communications regarding the vaccines in their portfolio.
• Reviews clinical safety and regulatory documents for vaccines in their portfolio in alignment with the medical strategy
• Defines overarching strategic opportunities and objectives for near mid and long term for the global medical affairs strategy for vaccines in their portfolio.
• Ensures integration of scientific information (including epidemiology disease burden modeling strain selection and public health value) in the asset strategy.
• Partners closely with Pfizer Vaccine R&D stakeholder groups (including Research Early and Late Development Regulatory Strategy Clinical Development and Operations) and other Global Medical Affairs Leads within Pfizer Vaccine R&D
• Ensures strategic alignment between CSI Medical and Research/Clinical in defining product concepts supports POM/POC development paths and participates in Program Strategic Groups for early vaccine candidates.
• Supports progression through governance milestones for preclinical and clinical development programs.
• Leads comprehensive evidence dissemination and medical communication strategy via external engagement and internal training with goal of communicating a streamlined scientifically robust narrative for each vaccine.
• Is responsible for proactively keeping up to date and informing the vaccines CSI and GAV cross-functional team of new clinical/scientific activities by competitors (e.g. new clinical trials disclosed in the public domain emerging data COVID strain evolution etc).
• Develops and implements competitive differentiation plans.
• Develops identifies funding and is accountable for delivering on the cross-functional multi-disciplinary research agenda for vaccines in their portfolio including epidemiology Phase 4 studies and outcomes research operationalized by Medical Affairs/Medical Evidence Generation/V&E and other cross-functional colleagues including:
  • Sets the research and data priorities including strategies to address data gaps. Accountable for delivering the approved research priorities.
  • Operationalizes evidence generation activities through research collaborations independent research support and Pfizer-sponsored studies.
  • Partners with Medical Evidence Generation group to develop study designs (e.g. surveillance methods; use of different diagnostic techniques; and molecular methods) and ensure implementation of epidemiology studies globally
  • Collaborates with experts in epidemiology statistics and data analysis to analyze and interpret study data
• Chairs (or delegates chair) the Global Medical Affairs Team (GMAT) and Evidence Generation Subcommittee for vaccines in the portfolio both of which review internal and external study proposals
• Oversees the publication strategy in partnership with internal and external research groups.
• Contributes to the scientific evidence base via publishing in peer-reviewed manuscripts and presenting at conferences.
• Represent the organization at key meetings and/or presents at key regulatory VTC or regulatory meetings.
• Lead and manages Seasonal Vaccines global medical team including direct report(s) and matrixed leadership
• Accountable for Medical Affairs and Medical Evidence Generation budget

BASIC QUALIFICATIONS

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.

• PhD or PharmD with 10 or more years of relevant experience
• Academic or comparable training in epidemiology required (MPH / MS / PhD / EIS)
• At least 5 years of pharmaceutical or biopharma industry with clinical development epidemiology and/or medical affairs experience
• Recognized subject matter expert in relevant infectious disease or vaccine research. Preferred experience in relevant seasonal vaccines (e.g. COVID-19 influenza)
• Demonstrated ability to influence and succeed through others. Able to form excellent relationships with key global and local cross-functional partners.
• Demonstrated success managing teams of highly skilled people
• Demonstrated ability to identify key data gaps develop a strategic evidence generation strategy and oversee implementation of epidemiological studies in support of clinical trial design and market access (VTC recommendations and reimbursement) globally.
• Able to review evaluate interpret and present complex data; understand the emerging safety and efficacy profile of the vaccine candidates and analyze published data and competitive intelligence to provide a comparison with standard of care and comparator vaccines.
• Excellent written communication skills including scientific -authorship (ideally first or last author) on at least 10 peer-reviewed publications in the past 3 years.
• Excellent verbal communication skills including demonstrated experience presenting technical evidence at influential meetings.
• Strong work ethic and proven track record of delivering high quality work on time.
• Entrepreneurial and motivated to challenge dogma and the status quo.
• Innovative in identifying new opportunities and finding new ways to create value.

PREFERRED QUALIFICATIONS

• Networking Credibility and approachability to establish and maintain important partnerships across functions.
• Accountability - for self and others - Takes personal accountability for outcomes and holds other accountable for their commitments.
• Grows Others - Actively coaches and develops others. Provides opportunities and experiences to develop skills and competencies.
• Leads Through Change Builds Change - Develops self and others in a way that enables a flexible and adaptable response to change. Demonstrates support for organizational and process changes.
• Teamwork a strong team player.
• Self-Awareness - Recognizes own strengths and limitations and personal motivations. Actively seeks feedback and knows ones impact on others. Acts with authenticity and maturity.
• Insight Influence & Inclusion - Understands other peoples unspoken as well as explicit concerns. Adapts own approach and behavior to be more effective and inclusive and to have positive impact on others.

PHYSICAL/MENTAL REQUIREMENTS

International travel.

NON-STANDARD WORK SCHEDULE TRAVEL OR ENVIRONMENT REQUIREMENTS

Ability to work at non-standard work hours international travel.

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