Senior Director, Global Medical Affairs, Lyme Disease Vaccine (non-MD)

ROLE SUMMARY

The Sr Director, Global Medical Affairs, Lyme Disease Vaccine is responsible for designing and executing the medical strategies leading to the licensure and public health implementation of a Lyme disease vaccine currently in phase 3 clinical trials. 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 Affairs, Lyme Disease Vaccine 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 Lyme disease, target age groups, risk factors, and outcomes and includes vaccine effectiveness and other post-licensure evaluations. 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 vector-borne 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

• Serves as subject matter for Lyme disease and Lyme disease vaccine
• Acts as key point of accountability for scientific inquiries and communications regarding Lyme disease. 
• Develops 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
• Ensures integration of scientific information (including epidemiology, disease burden, and public health value) in the asset strategy.
• 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.).
• Supports Lyme disease vaccine launch team
• Chairs the Lyme Disease Evidence Generation Subcommittee, which reviews 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 direct reports or budget accountability

BASIC QUALIFICATIONS

• PhD or PharmD with 8+ or more years’ experience
• Academic or comparable training in epidemiology required (MPH / MS / PhD / EIS)
• At least 8 years of medical and scientific experience in vaccines, essential.
• Able to influence and succeed through others.  Able to form excellent relationships with key global and local cross-functional partners.
• Demonstrated ability to identify key data gaps, develop an 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 verbal and written communication skills including scientific writing and presentation skills and