We are seeking a highly motivated individual to provide vision, strategy, and leadership in driving the implementation of precision medicine approaches for Seattle Genetics' development programs. This will entail devising and testing patient selection strategies and, when appropriate, the development of companion diagnostics, with the overall goal of identifying the right patients for our promising drug candidates. Collaborating with other groups in Translational Medicine and Clinical Development and with Research, the Diagnostics & Biomarkers group devises and executes strategies to understand mechanisms related to drug response and resistance and to evaluate clinical biomarkers in forming relationships between dose, pharmacodynamic responses, and clinical endpoints.
Develop, articulate, and lead the execution of overarching strategies for elucidating biomarkers of drug response and resistance and the clinical testing of associated hypotheses for patient selection
Lead collaborations with senior leaders in Research, Translational Medicine, and Clinical Development to identify potential tumor and immune correlates with response for research-stage programs to inform early development strategies
Maintain state-of-the art knowledge in the area by liaising with key opinion leaders on the use of diagnostic approaches and the use of biomarkers, particularly for targeted oncology and immuno-oncology therapies
Provide oversight of the development, validation, and execution of clinical biomarker assays, balancing the use of Contract Research Organizations (CROs) with, as appropriate, a strategic build-up and use of internal capabilities
In close collaboration with the Clinical Development Operations, Biometrics, and Bioinformatics functions, manage the timely testing of clinical trial samples and the analysis and reporting of the associated data
Maintain oversight of companion diagnostic partner evaluation & selection, completion of the associated work at CROs, and related regulatory activities
PhD, MD, or MD/PhD with 8+ years of experience (or equivalent) in a relevant scientific field (e.g. pathology, immunology, oncology, molecular biology, genetics)
Deep understanding of cancer biology, clinical oncology and/or immunology
Experience with the research and development of biologic therapeutics or similar academic experience, biomarker assay development, validation & execution in clinical trials
Experience and expertise in the development of companion diagnostics with direct involvement in regulatory submissions and interactions with regulatory authorities is preferred; but not absolutely necessary
Expertise and extensive experience with the development and validation of protein- and/or nucleic acid-based assays such as Flow Cytometry, IHC, PCR, genomic profiling and gene expression analysis
Understanding of clinical operations with the ability to implement well-designed experiments within a clinical trial environment
An understanding of translational approaches as applied to clinical trial design and regulatory processes, proof-of-concept studies, and the implementation of biomarkers and diagnostics
Excellent communication & organizational skills with a strong business acumen; able to convey complex scientific and business issues to devise, reach agreement on, and implement solutions
Ability to collaborate, lead, influence, and motivate others
As the leading employer in our industry in the Pacific Northwest, Seattle Genetics is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seattle Genetics, please visit www.seattlegenetics.com.
Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law.