Program Manager

2 weeks ago


Bethesda, United States Nextonic Solutions LLC Full time

Nextonic Solutions is seeking a highly ambitious, adaptable, structured, and detail-oriented Program Manager to join our vibrant team at the National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID), Vaccine Research Center (VRC), Vaccine Immunology Program (VIP).ResponsibilitiesResponsible for the overall day-to-day schedule management of the Vaccine Immunology Program portfolio of analyses and organization of testing plans with the stakeholders as designated by the Federal Task Leader.Monitor and assess the status of Vaccine Immunology Program projects through study lifecycle, including deadlines and other benchmarks to ensure that VRC activities are meeting stipulated obligations.Coordinate and author relevant clinical trial and testing documents.Apply technical knowledge to guide project decisions.Respond to requests from senior staff to accommodate changes in testing parameters and study designs.Communicate information to stakeholders on the status of activities at requested intervals.Liaise with the core elements of the Vaccine Immunology Program analytical clinical testing laboratories for the provision of resources: funding, analytical reagents, method optimization and novel assay development suitable to vaccines and biologics.Serve as a representative of the Vaccine Immunology Program on project teams clinical trial discussions for the VRC.Anticipate major problems and recognizes future program needs to accomplish clinical trial deliverables.Facilitates the resolution of conflicts among stakeholders and propose risk assessments as well as mitigation strategies to ensure project success.RequirementsBachelor's degree or higher in a biology-related discipline.Minimum of 3 years of experience in the pharmaceutical, vaccine, biologics, or similar industry is required.Experience managing aspects of clinical trial implementation and testing is preferred.Minimum of 2 years of experience in coordination and planning of commercial product or clinical trial projects.Knowledge of ICH and FDA guideline requirements for assay validation.Familiarity with immunoassays, including pharmacokinetics, anti-drug antibody, and neutralization assays.Visa Sponsorship: NoAgency / Institute: NIH/NIAID


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