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Senior Scientist III, DMPK Bioanalysis Project Representative/Lead

Company: AbbVie
Location: Crystal Lake
Posted on: September 15, 2019

Job Description:

The Drug Metabolism, Pharmacokinetics & Translational Modeling group within the DMPK-Bioanalysis (DMPK-BA) Department is seeking a DMPK project representative in Worcester, MA to provide project support enabling progression of novel drug candidates in discovery and early clinical development. The scientist will collaborate closely with Discovery project teams; developing and executing the DMPK and PKPD strategies necessary to facilitate the advancement of optimized candidate molecules. Key Responsibilities: Develop and drive the DMPK and pharmacokinetics-pharmacodynamics (PKPD) strategy for Discovery projects to support project decisions and milestones. Serve as a Drug Metabolism Pharmacokinetics and Bioanalysis (DMPK-BA) representative on project teams supporting the development of novel drug candidates (small molecules, biologics, antibody drug conjugates) for the treatment of diseases in Immunology, Oncology and Neuroscience. In this role, collaborate with project team members (Clinical Pharmacology, Discovery, Toxicology, etc.) and groups within DMPK-BA to generate relevant data to enable knowledge and data integration guiding target validation, biomarker selection, and candidate advancement Effectively communicate DMPK and PKPD strategy and knowledge to project teams, functional leaders, and other key stakeholders to ensure alignment and influence decisions. Analyze and integrate in silico, physicochemical, ADME, and DMPK data to support molecule design and selection with particularly attention to the impact of drug metabolism and drug-drug interactions In collaboration with key partners, develop PK/PD models that will generate data and knowledge to support robust translational and biomarker strategies. Coordinate and request PK, PKPD, and bio-analytical studies in a timely manner and communicate protocols, timelines, needs and results back to team, ensuring optimized cycle times Serve as a liaison with bio analytical groups to ensure timely reagent generation, method development and sample analysis Prepare DMPK-BA sections of regulatory documents (IB, IND, BLA); provide responses to regulatory questions and ensure generation of appropriate reports Bachelor with extensive (at least 14 years) experience, Masters with substantial (at least 12 years) experience, or Doctorate (Ph.D.) with at least 5 years experience in Pharmaceutical Sciences or related field Experience in independently representing DMPK on project teams is required Expertise with PK analysis and ADME is required Experience with Phoenix/WinNonlin modeling software is desired Understanding of PK/PD modeling and the essential elements of assays for measuring therapeutic molecules, assessing ADME properties, and biomarkers is important Demonstrated ability to function as principle investigator and scientific strategy leader; generating original scientific or development strategies and leading those efforts to an effective and productive outcome. Excellent communication skills Ability to influence, negotiate and communicate effectively with both internal and external stake holders. Ability to work well in a collaborative fast-paced team environment. Highly motivated, self-driven and results-oriented person with excellent communication and presentation skills, capable to work both as team player and project driver. High degree of flexibility in adapting to different projects, people and excellent networking and relationship-building (both internal and external) skills are required. Passion for data analysis, solving technical problems and applying new technologies to further scientific goals Key Leadership Competencies: Builds strong relationships with peers and cross functionally with partners outside of team to enable higher performance Learns fast, grasps the "essence" and can change course quickly where indicated Raises the bar and is never satisfied with the status quo Creates a learning environment, open to suggestions and experimentation for improvement Embraces the ideas of others, nurtures innovation and manages innovation to reality

Keywords: AbbVie, Crystal Lake , Senior Scientist III, DMPK Bioanalysis Project Representative/Lead, Other , Crystal Lake, Illinois

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