Principal Scientist, DMPK-BA Senior Biologics Project Representative

The Drug Metabolism, Pharmacokinetics, and Bioanalysis (DMPK-BA) group is searching for a senior leader with extensive experience as a 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 DMPK-BA and PK/PD strategies necessary to facilitate the advancement our pipeline.

Key Responsibilities:

• 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
• Develop and drive the DMPK-BA and PK/PD strategy for large molecule discovery, preclinical, and clinical development projects to support decisions and milestone transitions 
• 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 bioanalytical 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
• 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 DMPK-BA sections of regulatory documents (IB, IND, BLA); provide responses to regulatory questions and ensure generation of appropriate reports

Qualifications:

• Bachelor with extensive experience (14+ years), Masters with substantial experience (12+ years), or Doctorate (Ph.D.) with at least 6 years of experience in the pharmaceutical or biotechnology industries
• Experience independently representing DMPK-BA 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 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