Senior Manager Biomarkers and Diagnostics
The Senior Manager of Biomarkers and Diagnostics will participate in efforts to design and execute 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. The successful candidate will bring vision, strategy and leadership to develop and execute on biomarker and patient selection strategies to enable drug development candidates to move through clinical development. The successful candidate will also work and communicate with product team members from many disciplines outside of Translational Sciences, such as Clinical Development and Regulatory. Keys for success will include devising scientifically sound biomarker and diagnostic strategies, effective implementation of assays into clinical trials, and communicating data and program impacts to key stakeholders and project teams. This position has the option of being based in our Bothell, Seattle, or South San Francisco offices.
- Develop and execute strategies for elucidating biomarkers of drug response and resistance and the clinical testing of associated hypotheses for patient selection
- Collaborate with 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 on biomarker approaches, particularly for targeted oncology and immuno-oncology therapies
- Provide oversight of the development, validation, and execution of clinical biomarker assays,
- 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
- PhD, MD, or MD/PhD with 5+ 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 biomarker selection trials
- 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, Seagen 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 Seagen, please visit www.seagen.com.
Seagen 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.