Sr. Scientist III, Discovery Oncology DMPK Strategy
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, stem cells, apoptosis and cell-signaling with their knowledge of bispecific antibodies, antibody-drug conjugates (ADCs), and covalent-inhibitor technologies to discover and develop novel cancer treatments.
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 (incl. 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, bispecifics, and antibody drug conjugates
- Coordinate and request PK, PKPD, an 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 extensive (at least 14 years) experience, Masters with substantial (at least 12 years) experience, or Doctorate (Ph.D.) with at least 6 years 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 and 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
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
Equal Opportunity Employer Minorities/Women/Veterans/Disabled