Principal Scientist, Translational Clinical Biomarkers - Hematology/Oncology at Merck | Boston, MA, US | Rezi

Principal Scientist, Translational Clinical Biomarkers - Hematology/Oncology at Merck

Principal Scientist, Translational Clinical Biomarkers - Hematology/Oncology

Merck · Boston, MA, US

Yesterday

Principal Scientist, Translational Clinical Biomarkers - Hematology/Oncology

Merck · Boston, MA, US

a day ago
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About the Role

Seeking an accomplished Principal Scientist to provide strategic and scientific biomarker leadership for hematology programs, focusing on CML, BCR::ABL1-driven disease, and other myeloid malignancies. This role involves leading the development, execution, interpretation, and communication of translational and clinical biomarker strategies across all stages of clinical development.

Responsibilities

  • 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.
  • 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 co-existing 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.
  • Partner closely with Discovery, Clinical Development, Quantitative Sciences, Regulatory, Data Science, Clinical Operations, Pathology, Diagnostics, and other functions to develop integrated translational strategies.
  • Lead the interpretation of complex biomarker and clinical datasets, translating findings into clear, 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 biomarker strategies, results, scientific uncertainties, risks, and recommendations clearly 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.

Requirements

  • 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, including one or more relevant modalities such as NGS, quantitative PCR, molecular response/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 the ability to synthesize 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 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.
  • 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.
  • Regular employee status.
  • Domestic relocation.
  • No visa sponsorship.
  • 10% travel requirements.
  • Hybrid work arrangement.
  • 1st shift (Day) work.
  • No valid driving license required.

Skills

  • 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
  • Translational Medicine
  • Hematology
  • Molecular Biology
  • Translational Medicine
  • Pharmacology
  • Hematologic malignancies
  • Molecular drivers of disease
  • Treatment response
  • Resistance mechanisms
  • Clonal evolution
  • Molecularly targeted therapies
  • NGS
  • Quantitative PCR
  • Molecular response/MRD assays
  • Flow cytometry
  • Gene-expression profiling
  • Genomic approaches
  • Biostatistics
  • Bioinformatics
  • Quantitative sciences
  • Integrated biomarker data analysis
  • CML
  • BCR::ABL1 biology
  • Tyrosine kinase inhibitor development
  • Myeloid malignancies
  • Myeloproliferative neoplasms
  • Acute myeloid leukemia
  • Kinase domain mutations
  • Compound mutations
  • Co-occurring somatic alterations
  • Molecular response monitoring
  • BCR::ABL1 International Scale reporting
  • Major molecular response
  • Deep molecular response
  • Preclinical resistance profiling
  • Pharmacology
  • Longitudinal clinical molecular data
  • Differential sensitivity
  • Cross-resistance
  • Targeted therapies
  • Allosteric inhibitors
  • Registrational studies
  • Genomic data integration
  • Molecular data integration
  • Cellular data integration
  • Clinical outcomes integration
  • Diagnostic assay development
  • Companion diagnostics
  • Regulatory considerations
  • Mentoring scientists
  • External scientific collaborations
  • Scientific leadership

Location

  • USA - Pennsylvania - North Wales (Upper Gwynedd)

Work Type

  • Hybrid
  • Full-time

Experience Level

  • Principal

Education Level

  • Ph.D.
  • M.D.
  • Equivalent advanced scientific degree in hematology, oncology, molecular biology, translational medicine, pharmacology, or a related scientific discipline.

Salary/Compensations

  • $190,800.00 - $300,300.00

Benefits

  • Medical, dental, vision healthcare and other insurance benefits (for employee and family)
  • Retirement benefits, including 401(k)
  • Paid holidays, vacation, and compassionate and sick days.

About the Company

  • Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities.
  • We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds.
  • The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment.
  • We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Equal Opportunity

  • As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.
  • As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.
  • For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights
  • EEOC GINA Supplement
  • Learn more about your rights, including under California, Colorado and other US State Acts