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Pfizer Inc. Global Medical Affairs Lead, C. Difficile Vaccine (non-MD) in Denver, Colorado

The Global Medical Affairs Lead for C. difficile Vaccine is responsible fordesigning and executing the medical affairs strategies leading to thelicensure and introduction of the Pfizer C. difficile vaccine. This includesdeveloping the evidence generation strategy, engaging externalstakeholders, and collaborating with VRD and BU cross-functional teams tooptimize medical benefit and support vaccine recommendations globally.The Global Medical Affairs Lead for C. difficile vaccine is the lead forengaging the worldwide medical community to identify the unmet medical needfor C. difficile vaccine. He/she will manage relationships and activelybuild networks with key opinion leaders in the infectious diseases andvaccinology field, Vaccine Technical Committees (VTCs), healthcarepolicy makers, and payers, to obtain strategic input and establishresearch partnerships. He/she will develop a multi-disciplinary researchagenda that clearly defines the burden of CDI, target age groups, riskfactors, and outcomes and includes vaccine effectiveness and otherpost-licensure evaluations. He/she will develop vaccine target productprofiles with cross-functional partners, provide input on the clinicalprogram needed to obtain recommendations / reimbursement, and contributeto the regulatory strategy to optimize vaccine label. He/she willcollaborate with commercial and market access teams to develop appropriate,scientifically accurate marketing and access strategies, and propose medicalaffairs tactics to support these activities.This is a dynamic role that requires a firm understanding of the epidemiologyof infectious diseases, vaccine preclinical and clinical development, aswell as the ability to objectively interpret technical and commercialinformation in order to optimize clinical development as well as lifecyclestrategies. Leadership for local licensing and VTC recommendations are alsoneeded.ROLE RESPONSIBILITIESWorks closely with WRD to identify the unmet medical need for C. difficilevaccine and develops a cross-functional multi-disciplinary research agendaincluding epidemiology, clinical trials, outcomes research, policy,and implementation operationalized by clinical affairs/developmentoperations/statistics/HEOR and subject matter expertsEnsures clear cross-functional goals are established and agreed to.Operationalizes various evidence generation activities including explorationof research collaborations, independent research support, preparing studydata for medical queries, analysis and interpretation of data.Acts as key point of accountability for all scientific inquiries andcommunications regarding the C. difficile vaccine program.Works closely with the Scientific Affairs Lead C. difficile vaccine to developa holistic medical affairs plan where all the evidence generating activitiesare fully integrated and operationalized.Primary responsibility to review all regulatory documents for C. difficilevaccine.Defines overarching strategic portfolio opportunities and objectives fornear, mid, and long term for C. difficile vaccineEnsures strategic alignment between BU and WRD in defining product concepts,supports POM/POC development paths and participates in Program StrategicGroups for early candidates.Is responsible for proactively keeping up to date and informing the VaccinesBU team of new clinical/scientific activities by competitors (e.g. new,relevant clinical trials disclosed in the public domain, emerging data, etc.).Creates the publication strategy/implementation for C. difficile vaccine inpartnership with internal and external research groups.Basic qualificationsPhD or PharmD with 10 or more years experienceAt least 8 years of medical and scientific experience in vaccines, essential.Able to influence and succeed through others. Able to form excellentrelationships with key stakeholders in BU and WRD.Demonstrated ability in the design, initiation, and reporting of clinicalstudies as part of an integrated clinical plan.Able to review, evaluate, inter