Principal Scientist, Translational Clinical Biomarkers - Hematology/Oncology

MSD•Boston, MA

2d•$190,800 - $300,300•Hybrid

About The Position

The Principal Scientist provides strategic and scientific biomarker leadership across hematology programs, particularly chronic myeloid leukemia (CML), BCR::ABL1-driven disease, and other myeloid malignancies. The role leads the development, execution, interpretation, and communication of translational and clinical biomarker strategies across early and late clinical development, including programs involving targeted therapies and emerging therapeutic modalities. The scientist applies knowledge of hematologic disease biology, molecular drivers, clonal evolution, treatment response, and resistance mechanisms to create decision-centric biomarker strategies. These strategies support patient selection, dose and regimen optimization, molecular response assessment, resistance characterization, and differentiation from existing therapies, with an emphasis on rigorous, interpretable, actionable evidence that informs program decisions. The role represents biomarkers on cross-functional development teams, integrates evidence across development stages, and contributes to registrational strategies, potential companion diagnostic development, regulatory submissions, and health-authority interactions as appropriate. It also communicates results, uncertainties, risks, and recommendations to cross-functional teams and senior stakeholders, mentors biomarker scientists, and supports publications, collaborations, investigator-sponsored research, and engagement with external experts. The position is based in North Wales (Upper Gwynedd), Pennsylvania, with a hybrid work arrangement. Domestic relocation is listed, travel requirements are 10%, and the position is a regular employee role with a day shift. The salary range for the primary location is $190,800 to $300,300, with eligibility for an annual bonus and long-term incentive if applicable.

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, 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 relationships among 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, including the 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 that link scientific questions and measurements to expected outcomes and development actions.
Represent biomarkers on cross-functional development teams and provide strategic scientific input to program-level decisions.
Integrate translational evidence across early and late clinical development to support registrational strategies and differentiation from existing therapies.
Develop biomarker strategies incorporating relevant molecular drivers, 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 profiles, clinical outcomes, and treatment history.
Evaluate the clinical significance of baseline and treatment-emergent mutations, including effects on therapeutic sensitivity, cross-resistance, and treatment sequencing.
Develop approaches to distinguish disease-associated 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 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 for 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 biomarker strategies, results, 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.