Seagen
Senior Director - Clinical Biomarkers and Diagnostics
Development - Bothell, United States
Seagen is a global, multi-product biotechnology company dedicated to developing and commercializing transformative cancer medicines. As the industry leader in antibody-drug conjugate (ADC) technology, we pioneered a new generation in the science of harnessing antibodies to deliver cell-killing agents directly to cancer cells. Seagen’s dedication to improving the lives of cancer patients goes beyond science, and we believe that every employee has a role in contributing to this mission. By working together with a shared dedication and diverse perspectives, we are able to reach our full potential and make a real difference in the world. Seagen is a fast-growing company and has an abundance of opportunities available for you to grow your career. Put your passion to work at Seagen and join us!
Summary
Seattle Genetics is currently offering a unique opportunity for a highly motivated individual to lead the development of early diagnostics and companion diagnostics for our pipeline of targeted cancer therapies. The successful candidate must possess a deep understanding of clinical biomarker assay development, the commercial diagnostic landscape, the use of patient selection techniques to inform drug development and the development of companion diagnostics to support abbreviated clinical development plans. While the primary role of this position will focus on the development and clinical implementation of a companion diagnostic, the ideal candidate will also provide scientific and strategic input to support efficient decision making for our ongoing clinical trials. As an advisor to development project teams, as well as research and translational and commercial subteams, he/she will have the opportunity to work in a highly collaborative environment and to support projects throughout clinical development. The Senior Director will recruit and manage the Dx/CDx group within TBT and be responsible for the professional development of these team members.
Principal Responsibilities:
- Develop and deliver an overarching Oncology Diagnostic strategy, including integrating diagnostic activities into pipeline development and supporting accelerated approval development plans
- Develop strong relationships with preferred partners, contribute to partnership negotiations, ensure the development of high-quality work plans and data packages for companion diagnostics
- Manage and develop the Dx/CDx group within TBT
- Contribute to the development of global diagnostic regulatory submissions, respond to health authority questions, review labeling documents and significant risk determinations as needed
- Function as a scientific thought leader for diagnostic development and commercialization
- Lead and provide subject matter expertise to the use of patient selection strategies and diagnostic development for targeted oncology therapies
- Provide expertise in R&D, clinical development, and regulatory teams on relevant patient selection strategies related to key programs
- Manage diagnostic development through commercial launch
- Provide expertise to commercial teams to support product commercial launch and program lifecycle
- Must be able to work in fast paced work environment and participate in cross-functional teams in selecting methods, techniques and evaluation criteria to achieve business results
Qualifications:
- Candidates must have a PhD with relevant industry experience
- Demonstrated experience in the development of patient selection strategies and companion diagnostics, including in-depth knowledge of assay development, analytical validation, clinical validation and utilization of biomarkers in oncology
- Broad understanding of clinical development process and regulatory approval process of companion diagnostics
- Proven scientific/leadership expertise including the successful management and development of a highly skilled team
- Team management experience and cross-functional collaboration required
- Excellent verbal and written communication and presentation skills
- Minimum of 10 years' experience in industry or related setting
Education:
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.
To prevent the spread of COVID-19, and as an integral part of its public health and safety measures, Seagen requires that all newly-hired employees be fully vaccinated against COVID-19 before commencing employment, subject to reasonable accommodation and other requirements of applicable federal, state, and local law.
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Seagen
Seagen is an Equal Opportunity Employer
Submitted: 08/05/2022
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