Seeking a Sr. Scientist III, Discovery Oncology DMPK Strategy with a solid background in representing DMPK on biologics project teams and expertise with PK analysis of biologics.
Responsibilities: The Translational Modeling & Simulation department within the Drug Metabolism and Pharmacokinetics (DMPK) group is searching for a DMPK project representative in South San Francisco to provide project support enabling biologics progression (including antibody-drug conjugates (ADCs) and bi-specifics) in Oncology discovery and 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.
- Develop and drive the DMPK and PKPD strategy for Oncology Discovery projects to support project decisions and milestones.
- Serve as a DMPK-BA representative on project teams supporting the development of novel biologics (including ADCs and bi-specifics). 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 selection
- Effectively communicate DMPK and PKPD strategy and knowledge to project teams, functional leaders, and other key stakeholders to ensure alignment and influence decisions.
- Demonstrate thorough understanding of the PKPD and DMPK aspects necessary for the selection and characterization of antibodies, bi-specifics, and antibody drug conjugates
- Coordinate and request PK, PKPD, and bio-analytical (BA) 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 14 years of experience, Masters with 12 years of experience, or Doctorate (Ph.D.) with 6 years of experience in Pharmaceutical Sciences or related field
- Experience in independently representing DMPK on biologics project teams is required (expertise in ADC development 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 ligand binding assays for measuring biologic molecules and/or biomarkers in pre-clinical study samples is desired
- 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.
- Recognized expert in his/her discipline
- Experienced/demonstrated publication or patent record, with lead/senior author examples a plus
- 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
- 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
- U.S. Citizen/green card holder required