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Sr Principal Scientist/Assoc Director, PK Sciences, Immunology

Management

Executive Director

No

Cambridge, Massachusetts, United States

50 + projects are being supported in the Immunology Therapeutic Area within the PK Sciences department. We provide PK and PKPD strategies from early discovery all the way through to registration and beyond. About half of this portfolio represents biologics projects spanning from classical monoclonal antibodies to complex biologics constructs and extending to T-cell therapies., including CAR-Tcell modalities and T-cell engagers. Our Team likes to expand by adding an experienced Team member who will drive our biologics projects. <br><br>As a Sr Principal Scientist/Assoc Director within the PK Sciences, Immunology group your responsibilities will include, but are not limited to: <br><br>• Independently represents PK Sciences a core member of discovery, translational medicine and global project teams and leads PKS sub-team to define PKS strategy for compound progression and development.<br>• Analyze and interpret PK//PD/IG data generated during discovery, early and full development; present results to the program.<br>• Proactively identifies potential project hurdles, provides solutions and contributes to contingency plans. <br>• Independently authors and prepares key clinical, and regulatory documents including, but not limited to: clinical study protocols, clinical study reports, modeling reports, investigator brochures, IND / IMPDs and NDAs within agreed timelines, and meeting all regulatory requirements. <br>• Publishes internally or externally as main contributor to enhance Novartis and PK Sciences visibility.<br><br>The position will be located at our Cambridge, MA site and will not have the ability to be located remotely.<br><br>[#video#https://www.youtubeno-cookie.com/embed/elrQqCcdeqI{#400,300#}#/video#]