Our client is seeking a highly motivated Scientist, Assay Development, to play a critical role in advancing oncology programs from preclinical development through clinical trials. This individual will contribute to the identification, development, and implementation of biomarker strategies that support patient selection, pharmacodynamic assessment, and mechanistic understanding of novel therapeutics.
The ideal candidate is a hands-on scientist with strong experience in biomarker assay development and translational research who thrives in a fast-paced, collaborative environment and is excited to make a direct impact on the development of innovative cancer therapies.
Qualifications of the Scientist, Assay Development
PhD (or equivalent advanced degree) in immunology, oncology, molecular biology, or a related discipline. Bachelors with 8+ years of experience and Masters with 5+ years of experience will be considered.
3+ years of industry experience in oncology drug development, translational research, or biomarker development.
Strong understanding of drug development processes, including experience supporting IND-enabling studies and early-phase clinical trials.
Demonstrated hands-on experience developing and executing biomarker assays and analyzing patient specimens using techniques such as, IHC / IF, ISH, ELISA, ELISPOT, Flow cytometry (preferred)
Excellent communication and collaboration skills, with the ability to work effectively across cross-functional teams.
Proven ability to operate independently in a dynamic, fast-paced biotechnology environment while managing multiple priorities.
Responsibilities of the Scientist, Assay Development:
Lead the development and implementation of translatable biomarkers to support oncology programs across preclinical and clinical stages, including biomarkers for patient selection, drug response monitoring, pharmacodynamics, and mechanism of action.
Design, develop, and validate biomarker assays, and establish standardized operating procedures (SOPs) to ensure reliable and reproducible biomarker quantification using patient-derived specimens.
Contribute to the overall biomarker and translational strategy for clinical trials, ensuring scientific rigor and alignment with program objectives.
Collaborate closely with biospecimen, clinical operations, and translational teams to optimize and standardize sample handling and processing workflows to support clinical study readiness.
Manage relationships with external CROs and vendors responsible for outsourced biomarker assay development, validation, and execution, ensuring adherence to timelines, quality standards, and regulatory expectations.
Analyze and interpret biomarker data to generate actionable insights into treatment response, pharmacodynamics, and mechanisms of action.
Partner with regulatory and clinical teams to ensure biomarker strategies support IND-enabling activities and regulatory submissions.
Occupational Category: 19-1029 Biological Scientists, All Other
Application Instructions: Please apply using the form or send your resume to Surf Search.
