Principal Research Scientist I, DMPK Senior Biologics Project Representative

4 weeks ago


North Chicago Illinois, United States AbbVie Full time
Job Description

The AbbVie portfolio consists of several marketed products in areas including eye care, immunology, oncology, virology, and women’s health as well as a pipeline containing multiple promising new molecules being studied in hundreds of clinical trials or advancing from Discovery into Development. AbbVie is a global organization with US research sites in Boston (Cambridge and Worcester, MA), Chicago (North Chicago, IL), and the San Francisco Bay Area (South San Francisco, CA). The biologics portfolio is comprised of diverse and tailored modalities including mono- and bispecific antibodies, antibody-drug conjugates, dual variable domain antibodies, antibody fragments, and other recombinant proteins as well as cell-based therapies.

The Quantitative, Translational and ADME Sciences (QTAS) group is searching for an experienced project representative to provide biologics project support across all therapeutic areas for molecules in discovery and clinical development. The position requires close collaboration with Discovery and Development project teams, clinical pharmacology, and other stakeholders, developing and executing QTAS and PK/PD strategies necessary to facilitate the advancement of our pipeline.

The Project Representative will be based in one of AbbVie's R&D locations: North Chicago, IL; Worcester, MA; Cambridge, MA; San Francisco, CA.

Key Responsibilities:

Serve as a QTAS representative on project teams supporting the development of novel biologics; collaborate with project team members (e.g., clinical pharmacology, protein analytics, discovery, toxicology) and groups within QTAS to generate relevant data guiding target validation, biomarker selection, and candidate selection

Develop and drive the QTAS and PK/PD strategy for large molecule discovery, preclinical, and clinical development projects  to support decisions and milestone transitions

Effectively communicate QTAS and PK/PD strategy and knowledge to project teams, functional leaders, and other key stakeholders to ensure alignment and influence decisions.

Demonstrate thorough understanding of the PK/PD and  bioanalytical aspects necessary for the selection and characterization of antibodies, including considerations for bispecific antibodies, antibody-drug conjugates, and novel modalities

Coordinate and request PK, PK/PD, and bioanalytical studies in a timely manner and communicate protocols, timelines, needs and results back to team, ensuring optimized cycle times

Conduct value-added PK/PD-related quantitative analyses to support project team or project strategy decision-making

Serve as a liaison with bioanalytical groups to ensure timely reagent generation, method development and sample analysis

Prepare QTAS sections of regulatory documents (IB, IND, BLA); provide responses to regulatory questions and ensure generation of appropriate reports



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