Seagen
Associate Director Clinical Assays and Companion Diagnostics
Translational Sciences Bothell, Washington - South San Francisco, California
Description
Summary
The Associate Director of Companion Diagnostics will oversee companion diagnostic strategy of multiple late and early stage clinical oncology development programs. The successful candidate will bring strategic leadership to define clinically and commercially viable patient selection strategies to enable drug development candidates to move through clinical development while collaborating closely with members of the Clinical Development, Regulatory and Commercial functions. Keys for success include leading cross-functional groups to deliver scientifically and commercially sound recommendations for diagnostic testing in patient selection trials and companion diagnostic strategies for both early and late-stage programs, flexibility and creativity in incorporating companion diagnostic development timing and communicating data and program impacts to key stakeholders and project teams. This position has the option of being based remotely or in either of our Bothell, Seattle, or South San Francisco offices.
Responsibilities:
- Design clear strategic recommendations for incorporating clinical testing and companion diagnostic development into patient selection trials incorporating scientific, regulatory, commercial and global considerations
- Provide oversight of the integration of clinical assays or IVDs into clinical trials including reviewing sections of clinical protocols, lab manuals and/or ICFs.
- Author key sections of regulatory documents and represent Seagen at regulatory interactions.
- Collaborate with the Clinical Development Operations, Regulatory and Commercial functions to drive diagnostic and clinical testing strategy from IND to Launch.
Requirements:
- PhD, MD, or MD/PhD with 5+ years of experience in a relevant work experience developing biomarker and companion diagnostics
- Experience and expertise in biomarker selection trials
- Experience with developing and documenting clinical and regulatory strategies in coordination with clinical plans and marketing objectives.
- Experience with communicating precision-medicine strategy, issues, and risks in written and verbal format to company senior leadership team and other governing bodies.
- Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders.
- Excellent communication, analytical and organizational skills.
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.
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Seagen
Seagen is an Equal Opportunity Employer
Submitted: 04/02/2021
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