Principal Scientist, Translational Clinical Biomarkers - Hematology/Oncology

Merck4 Locationsonsite$191k–$300kView the original posting at Merck ↗

Job Description We are seeking an accomplished and highly motivated Principal Scientist to provide strategic and scientific biomarker leadership across programs within our hematology portfolio, with a particular focus on chronic myeloid leukemia (CML), BCR::ABL1-driven disease, and other myeloid malignancies. This role will lead the development, execution, interpretation, and communication of translational and clinical biomarker strategies across programs spanning early through late clinical development, including targeted therapies and emerging therapeutic modalities. The successful candidate will bring a strong understanding of hematologic disease biology, molecular drivers, clonal evolution, treatment response, and resistance mechanisms. They will translate these insights into decision-centric biomarker strategies that inform clinical development, including patient selection, dose and regimen optimization, molecular response assessment, resistance characterization, and differentiation from existing therapies. Biomarker strategies should prioritize generation of scientifically rigorous, interpretable, and actionable evidence that informs program decisions rather than data generation alone. Key Responsibilities Biomarker Strategy and Clinical Development * Develop and lead integrated translational and clinical biomarker strategies across hematology programs, with particular emphasis on CML and other myeloid malignancies. * Translate hematologic disease biology, therapeutic mechanisms, and molecular heterogeneity into clear translational hypotheses and fit-for-purpose biomarker approaches. * Define how biomarkers can inform key development questions, including proof of biology, target engagement, dose and regimen selection, patient selection, molecular response, resistance mechanisms, and go/no-go decisions. * Develop focused, scalable biomarker plans that clearly connect scientific questions, proposed measurements, expected outcomes, and potential development actions. * Serve as the biomarker representative on cross-functional development teams, providing scientific leadership and strategic biomarker input to program-level decision-making. * Integrate translational evidence across early and late clinical development to support registrational strategies and differentiation from existing therapeutic options. Hematology Disease Biology and Molecular Biomarkers * Develop biomarker strategies incorporating disease-relevant molecular drivers, including BCR::ABL1 kinase domain mutations, alternative resistance mechanisms, and co-occurring somatic alterations, as appropriate to the program. * Characterize molecular heterogeneity, clonal evolution, treatment-emergent resistance, and biological determinants of therapeutic response. * Integrate molecular response and measurable residual disease (MRD) assessments with mutation profiling, clinical outcomes, and treatment history. * Evaluate the clinical significance of baseline and treatment-emergent mutations, including their potential impact on therapeutic sensitivity, cross-resistance, and treatment sequencing. * Develop approaches to distinguish disease-associated molecular alterations from coexisting clonal hematopoiesis, where relevant. * Apply disease-appropriate molecular and cellular biomarker technologies, including next-generation sequencing, quantitative PCR, digital PCR, flow cytometry, and other emerging analytical approaches. * Interpret preclinical pharmacology, mutation-specific sensitivity, clinical exposure, and longitudinal molecular response data to inform translational hypotheses and development decisions. * Support patient-selection and precision-medicine strategies using molecular, genomic, cellular, and other disease-relevant biomarkers. Cross-Functional Leadership and Scientific Integration * Partner closely with Discovery, Clinical Development, Quantitative Sciences, Regulatory, Data Science, Clinical Operations, Pathology, Diagnostics, and other functions to de

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