Principal Scientist, Translational Clinical Biomarkers - Hematology/Oncology

Merck•Boston, MA

1d•$190,800 - $300,300•Hybrid

About The Position

We are seeking an accomplished and highly motivated Principal Scientist to provide strategic and scientific biomarker leadership across programs within the hematology portfolio, particularly chronic myeloid leukemia (CML), BCR::ABL1-driven disease, and other myeloid malignancies. This role leads 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 brings a strong understanding of hematologic disease biology, molecular drivers, clonal evolution, treatment response, and resistance mechanisms. They 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. Strategies prioritize scientifically rigorous, interpretable, and actionable evidence that informs program decisions. The role serves as the biomarker representative on cross-functional development teams, provides scientific leadership and strategic input to program-level decisions, and contributes to companion diagnostic strategies, regulatory submissions, publications, external collaborations, and scientific engagement. It also provides guidance and mentorship to biomarker scientists. The position is based primarily in North Wales, Pennsylvania, and is hybrid, with 10% travel and a day shift. Domestic relocation is available; visa sponsorship is not available.

Requirements

Ph.D., M.D., or equivalent advanced scientific degree in hematology, oncology, molecular biology, translational medicine, pharmacology, or a related scientific discipline.
Significant experience developing and executing translational or clinical biomarker strategies in hematology or oncology drug development.
Strong scientific understanding of hematologic malignancies, particularly molecular drivers of disease, treatment response, resistance mechanisms, and clonal evolution.
Demonstrated ability to translate disease biology and therapeutic mechanisms into biomarker strategies that inform clinical development decisions.
Working knowledge of molecularly targeted therapies and the relationship between pharmacology, disease biology, resistance mechanisms, clinical endpoints, and development strategy.
Experience interpreting molecular and cellular biomarker data using one or more relevant modalities, such as NGS, quantitative PCR, molecular response or MRD assays, flow cytometry, gene-expression profiling, or other genomic approaches.
Ability to critically evaluate preclinical and clinical evidence, including molecular resistance data, and translate findings into meaningful development recommendations.
Demonstrated experience leading cross-functional scientific activities in a matrixed organization and influencing decisions without direct authority.
Strong analytical and problem-solving skills, including synthesizing complex, multidimensional datasets into clear, decision-oriented conclusions.
Ability to prioritize high-value, decision-enabling biomarker work and distinguish it from lower-priority exploratory activities.
Excellent written and verbal communication skills and ability to convey scientific strategy to multidisciplinary stakeholders.
Working knowledge of biostatistics, bioinformatics, quantitative sciences, and integrated biomarker data analysis.
Strategic mindset emphasizing scientific rigor, prioritization, scalability, and actionable evidence.
Required skills listed: biomarkers, clinical development, clinical research, ethical compliance, immuno-oncology, mechanism of action, oncology, patient care, pharmacodynamics, protocol development, research designs, scientific presentations, scientific writing, strategic thinking, and translational medicine.

Nice To Haves

Direct experience with CML, BCR::ABL1 biology, and tyrosine kinase inhibitor development, including mechanisms of sensitivity and resistance.
Experience with other myeloid malignancies or hematologic diseases, including myeloproliferative neoplasms, acute myeloid leukemia, or related disorders.
Experience evaluating kinase domain mutations, compound mutations, co-occurring somatic alterations, and their relationships with treatment response or resistance.
Familiarity with molecular response monitoring in CML, including BCR::ABL1 International Scale reporting, major molecular response, deep molecular response, and relevant treatment-response guidelines.
Experience integrating preclinical resistance profiling, pharmacology, and longitudinal clinical molecular data to evaluate differential sensitivity and cross-resistance.
Experience supporting targeted therapies, including tyrosine kinase inhibitors, allosteric inhibitors, or other emerging therapeutic modalities.
Experience supporting hematology programs across multiple stages of clinical development, including late-stage or registrational studies.
Experience integrating genomic, molecular, and cellular biomarker data with clinical outcomes.
Familiarity with diagnostic assay development, companion diagnostics, and associated regulatory considerations.
Experience mentoring scientists, supporting external scientific collaborations, or providing scientific leadership across multiple development programs.

Responsibilities

Develop and lead integrated translational and clinical biomarker strategies across hematology programs, particularly CML and other myeloid malignancies.
Translate disease biology, therapeutic mechanisms, and molecular heterogeneity into translational hypotheses and fit-for-purpose biomarker approaches.
Define how biomarkers can inform 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 connecting scientific questions, proposed measurements, expected outcomes, and potential development actions.
Represent biomarker science on cross-functional development teams and provide strategic input to program-level decision-making.
Integrate translational evidence across early and late clinical development to support registrational strategies and differentiation from existing therapies.
Develop strategies incorporating disease-relevant molecular drivers, including BCR::ABL1 kinase domain mutations, alternative resistance mechanisms, and co-occurring somatic alterations.
Characterize molecular heterogeneity, clonal evolution, treatment-emergent resistance, and biological determinants of therapeutic response.
Integrate molecular response and measurable residual disease assessments with mutation profiling, clinical outcomes, and treatment history.
Evaluate the clinical significance of baseline and treatment-emergent mutations, including potential effects 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 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.
Partner with Discovery, Clinical Development, Quantitative Sciences, Regulatory, Data Science, Clinical Operations, Pathology, Diagnostics, and other functions to develop integrated translational strategies.
Lead interpretation of complex biomarker and clinical datasets and translate findings into actionable recommendations.
Evaluate emerging biomarker technologies and analytical approaches based on their ability to address meaningful development questions.
Contribute to biomarker strategies supporting potential companion diagnostic development, regulatory submissions, and interactions with health authorities, as appropriate.
Communicate strategies, results, scientific uncertainties, risks, and recommendations to cross-functional teams, governance groups, and senior stakeholders.
Provide scientific guidance and mentorship to biomarker scientists and contribute to a collaborative, strategically focused biomarker organization.
Support scientific publications, external collaborations, investigator-sponsored research, and interactions with key opinion leaders and external experts.