M
Not Specified Permanent

Cambridge, Massachusetts · USA job

Principal Scientist, Translational Clinical Biomarkers - Hematology/Oncology

Merck Sharp & Dohme (MSD)

Cambridge, Massachusetts

Job description

Overview

In this role you will lead integrated translational and clinical biomarker strategies across oncology and hematology programs, guiding decisions from early development through late-stage trials. You'll translate biology into testable hypotheses and ensure biomarker plans inform go/no-go decisions and dose/regimen choices. You will collaborate across discovery, clinical development, regulatory, and data science to deliver high-value evidence that shapes program direction. This is a strategic, cross-functional leadership role focused on rigorous, scalable biomarker science with meaningful impact.

Compensation / Benefits
  • annual bonus
  • long-term incentive
  • comprehensive benefits package
  • health, dental, vision insurance
  • retirement benefits (401(k
  • paid holidays, vacation, and sick days
Responsibilities
  • Develop and lead integrated biomarker strategies across oncology and hematology programs with cross-functional teams
  • Translate disease biology and mechanism into translational hypotheses and fit-for-purpose biomarker approaches
  • Define how biomarkers inform development questions including proof of biology, target engagement, dose selection, patient selection, response assessment, and resistance
  • Ensure strategies are focused, scalable, and linked to actions and outcomes
  • Serve as biomarker representative on cross-functional program teams and provide strategic input
  • Collaborate with Discovery, Clinical Development, Quantitative Sciences, Regulatory, Data Science, Clinical Operations, Pathology, Diagnostics, and other functions
  • Lead interpretation of biomarker and clinical datasets and translate findings into actionable recommendations
  • Characterize disease heterogeneity, molecular drivers, treatment response, resistance mechanisms, and biological determinants of outcomes
  • Develop and evaluate patient-selection and precision-medicine strategies across genomic, transcriptomic, proteomic, and other biomarkers
  • Apply circulating and tissue-based biomarker approaches (ctDNA, MRD, profiling, immunophenotyping, PD biomarkers) as appropriate
  • For hematologic malignancies, incorporate molecular response, MRD, clonal evolution, mutational burden, lineage/phenotype, and resistance alterations
  • For solid tumors, address target expression, tumor biology, molecular subtype, immune contexture, circulating biomarkers, and predictive markers
  • Evaluate emerging biomarker technologies and analytical approaches for development impact
  • Contribute to biomarker strategies supporting companion diagnostics or regulatory biomarker development
  • Communicate biomarker strategies, results, risks, and recommendations clearly to stakeholders
  • Provide scientific guidance and mentorship to biomarker scientists and foster collaboration
  • Support publications, scientific presentations, and external collaborations
Key requirements
  • Significant experience developing and executing translational or clinical biomarker strategies in oncology or hematology drug development
  • Strong scientific expertise in cancer biology, hematologic malignancies, translational oncology, or related discipline
  • Demonstrated ability to translate hypotheses into biomarker strategies that inform clinical development decisions
  • Solid understanding of mechanism of action, disease biology, heterogeneity, pharmacology, biomarkers, endpoints, and development strategy
  • Experience with biomarker modalities such as NGS, ctDNA, MRD, immunohistochemistry, flow cytometry, gene-expression profiling, proteomics, or similar
  • Ability to lead cross-functional work in a matrixed environment and influence without direct authority
  • Strong analytical and problem-solving skills to synthesize complex data into decision-oriented conclusions
  • Ability to prioritize high-value biomarker work to enable decisions
  • Excellent written and verbal communication skills for stakeholder engagement
  • Working knowledge of biostatistics, bioinformatics, quantitative sciences, and multidimensional biomarker data analysis
  • Strategic mindset focused on scientific rigor, prioritization, scalability, and actionable evidence
  • Strategic thinking
  • Collaborative leadership
  • Clear scientific communication
  • Biomarker strategy development
  • Translational medicine
  • NGS / ctDNA / MRD

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