Senior Director, Global Medical Strategy, C. difficile and Bacterial Pipeline Vaccines (NMD)

ROLE SUMMARY

The Sr. Director, Global Medical Strategy, C. difficile and Bacterial Pipeline Vaccines is responsible for designing and executing the medical strategies leading to the licensure and public health implementation of vaccines in their portfolio. 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 Sr Director, Global Medical Strategy, C. difficile and Bacterial Pipeline Vaccines will manage relationships and actively build networks with key opinion leaders 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 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, and vaccine policy and implementation, as well as the ability to objectively interpret technical and commercial information in order to optimize clinical development, market access, and lifecycle strategies. Leadership for local licensing and VTC recommendations are also needed.

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. 
• Is responsible for reviewing all clinical and regulatory documents for vaccines in their portfolio.
• Defines overarching strategic portfolio opportunities and objectives for near, mid, and long term for vaccines in their portfolio.
• Ensures integration of scientific information (including epidemiology, disease burden, and public health value) in the asset strategy.
• 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.  
• 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, relevant clinical trials disclosed in the public domain, emerging data, etc.).
• Develops and implements competitive differentiation plans.
• Acts as global medical lead for vaccine launches (when time arises).
• Develops and identifies funding for a cross-functional multi-disciplinary research agenda including epidemiology, clinical trials, outcomes research, policy, and implementation 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
  • Operationalizes evidence generation activities through exploration of research collaborations, independent research support, and Pfizer-sponsored studies.
  • Partners with Medical Evidence Generation group to develop generic study designs that will be used globally for epidemiological studies (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
• Creates and operationalizes 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.

Management and budget accountability

• No dir