- 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
- Bachelor with extensive experience (14+ years), Masters with substantial experience (12+ years), or Doctorate (Ph.
- Experience independently representing QTAS on biologics project teams is required (expertise with novel modalities is preferred)
- Expertise with PK analysis of biologics and relevant data analysis software such as Phoenix/WinNonlin is required
- Familiarity with modeling software such as MATLAB/SimBiology, R, Python, or Berkeley Madonna is desired
- Understanding of biologics PK/PD modeling and analytical assays for measuring biologic molecules and biomarkers (including ligand binding and mass spectrometry assays) in preclinical study samples is desired
- Demonstrated scientific leadership including generating original scientific investigative strategies and guiding those efforts to an effective and productive outcome
- Recognized expert in his/her discipline
- Demonstrated publication or patent record; lead/senior author contributions a plus
- Ability to influence, negotiate and communicate effectively with both internal and external stakeholders; ability to work well in a collaborative fast-paced team environment
- Highly motivated, self-driven and results-oriented with excellent communication and presentation skills; capable of working both as team player and project driver
- High degree of flexibility in adapting to different projects and people; excellent networking and relationship-building (both internal and external) skills
- Passion for data analysis, solving technical problems and
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Principal Research Scientist I, DMPK Senior Biologics Project Representative - North Chicago, United States - AbbVie, Inc
Description
Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow.
We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio.
For more information about AbbVie, please visit us at Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.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:
Qualifications
