Principal Scientist, DMPK Oncology Project Lead

Oncology is a key therapeutic area for AbbVie, with a portfolio consisting of three marketed products-Imbruvica, Venclexta, and Empliciti-and a pipeline containing multiple promising new molecules that are being studied in nearly 200 clinical trials in 19 different types of cancer. AbbVie is expanding its oncology organization focusing on the discovery and development of novel oncology therapies. More than 1,000 AbbVie scientists, clinicians, and product developers with strong entrepreneurial roots combine their expertise in immuno-oncology, cell therapies, apoptosis and cell-signaling with their knowledge of bispecific antibodies, antibody-drug conjugates, and covalent inhibitor technologies to discover and develop novel cancer treatments.

The Drug Metabolism, Pharmacokinetics, and Bioanalysis (DMPK-BA) group is searching for a project representative in Lake County IL to provide biologics project support (incl. antibody-drug conjugates and bispecific antibodies) in Oncology discovery and Clinical Development. The position requires close collaboration with Discovery project teams and other stakeholders, developing and executing DMPK-BA and PK/PD strategies necessary to facilitate the advancement of optimized candidate molecules.

Key Responsibilities:

• Develop and drive the DMPK-BA and PK/PD strategy for large molecule Oncology discovery and preclinical projects to support decisions and milestone transitions
• Serve as a DMPK-BA 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 DMPK to generate relevant data guiding target validation, biomarker selection, and candidate selection
• Effectively communicate DMPK-BA 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 DMPK aspects necessary for the selection and characterization of antibodies, including bispecific antibodies and antibody-drug conjugates
• 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
  
• Serve as a liaison with bioanalytical 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

Level and compensation will be commensurate with experience

• Bachelor with extensive (at least 14 years) experience, Masters with substantial (at least 12 years) experience, or Doctorate (Ph.D.) with at least 6 years of experience in the oncology pharmaceutical or biotechnology industries
• Experience independently representing DMPK on biologics project teams is required (expertise with antibody-drug conjugates is a plus)
• Expertise with PK analysis of biologics is required
• Experience with Phoenix/WinNonlin modeling software is desired
• Understanding of biologics PK/PD modeling and analytical assays for measuring biologic molecules and/or 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 as a subject matter 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 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