The Manager of Clinical Biomarkers & Diagnostics Operations will review and develop operational processes in support of late and early-stage clinical oncology development programs. The primary role of this position will include streamlining and standardizing operations with a focus on vendor assessments and functional process improvements. This position has the option of being based remotely or in either of our Bothell, Seattle, or South San Francisco offices.
Responsibilities:
Streamline and standardize operations within the scope of the Companion Diagnostic function.
Support vendor interactions, audits and contracting.
Manage clinical trial assay result workflows
Author and review SOPs, trial protocols, ICFs and assay sections of regulatory documents
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Candidates must have a Ph.D or 5+ relevant industry experience.
Expertise in clinical trial operations, with a focus on biomarker testing and reporting.
Expertise in assay methodologies such as in situ hybridization, immunoassays, immunohistochemistry, PCR and NGS.
Experience communicating development plans, issues, and risks in written and verbal format.
Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders.
Excellent communication, analytical and organizational skills.
Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.