Principal Scientist, Translational Clinical Biomarkers - Hematology/Oncology

Job Description

We are seeking an accomplished and highly motivated Principal Scientist to provide strategic and scientific biomarker leadership across programs within the Oncology and Hematology portfolios.

This role will lead the design, execution, analysis, and communication of translational and clinical biomarker strategies across programs spanning early through late clinical development.

The successful candidate will develop decision-centric biomarker strategies that integrate therapeutic mechanism, tumor or disease biology, pharmacodynamics, molecular heterogeneity, patient selection, response and resistance, dose and regimen selection, and clinical endpoints. Biomarker plans should focus on generating high-value, interpretable evidence that informs program decisions rather than data generation alone.

Key Responsibilities

* Develop and lead integrated biomarker strategies across oncology and hematology programs, in partnership with cross-functional development teams.

* Translate disease biology and therapeutic mechanism 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, response assessment, resistance mechanisms, and go/no-go decisions.

* Ensure biomarker strategies are focused and scalable, with clear linkage between the development question, proposed measurement, expected result, and potential action.

* Serve as the biomarker representative on cross-functional program teams and provide strategic biomarker input to program-level decision making.

* Partner closely with Discovery, Clinical Development, Quantitative Sciences, Regulatory, Data Science, Clinical Operations, Pathology, Diagnostics, and other functions to develop integrated translational strategies.

* Lead interpretation of biomarker and clinical datasets and translate complex findings into clear, actionable recommendations.

* Develop approaches to characterize disease heterogeneity, molecular drivers, treatment response, mechanisms of resistance, and biological determinants of clinical outcome.

* Develop and evaluate patient-selection and precision-medicine strategies, including approaches based on genomic, transcriptomic, protein-expression, cellular, or other disease-specific biomarkers.

* Apply circulating and tissue-based biomarker approaches, as appropriate, including ctDNA, minimal residual disease, molecular profiling, immunophenotyping, and pharmacodynamic biomarkers.

* For hematologic malignancies, develop strategies incorporating disease-relevant measures such as molecular response, measurable residual disease, clonal evolution, mutational burden, lineage or cellular phenotype, and resistance-associated alterations, as appropriate to the program.

* For solid tumors, develop strategies addressing target expression, tumor biology, molecular subtype, immune contexture, circulating biomarkers, mechanisms of response and resistance, and potential predictive biomarkers.

* Evaluate emerging biomarker technologies and analytical approaches based on their ability to address meaningful development questions and influence program decisions.

* Contribute to biomarker strategies supporting potential companion diagnostic or regulatory biomarker development, where appropriate.

* Communicate biomarker strategies, results, risks, and recommendations clearly to cross-functional teams, governance groups, and key stakeholders.

* Provide scientific guidance and mentorship to biomarker scientists and contribute to a collaborative, strategically focused biomarker organization.

* Support publications, scientific presentations, external collaborations, and interactions with key external experts as appropriate.

Qualifications

Education

Ph.D., M.D., or equivalent advanced scientific degree with relevant experience in oncology, hematology, translational medicine, biomarker science, drug development, or a related discipline.

Required Experience and Skills

* 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 a related discipline.

* Demonstrated ability to translate scientific hypotheses into biomarker strategies that inform clinical development decisions.

* Strong understanding of the relationship between mechanism of action, disease biology, molecular heterogeneity, pharmacology, biomarkers, clinical endpoints, and development strategy.

* Experience with one or more relevant biomarker modalities, such as NGS, ctDNA, MRD, immunohistochemistry, flow cytometry, gene-expression profiling, proteomics, or other molecular and cellular approaches.

* Ability to lead cross-functional scientific work in a matrixed environment and influence without direct authority.

* Strong analytical and problem-solving skills, including the ability to synthesize complex and 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 communicate scientific strategy to stakeholders.

* Working knowledge of biostatistics, bioinformatics, quantitative sciences, and multidimensional biomarker data analysis.

* Strategic mindset with a focus on scientific rigor, prioritization, scalability, and generation of actionable evidence.

Preferred Experience and Skills

* Experience supporting oncology or hematology programs across multiple stages of clinical development.

* Experience with predictive, pharmacodynamic, prognostic, resistance, MRD, or precision-medicine biomarker strategies.

* Experience integrating tissue, blood, molecular, and cellular biomarker data with clinical outcomes.

* Experience supporting biomarker strategies for targeted therapies, immune-based therapies, antibody-drug conjugates, cell therapies, bispecifics, or other novel therapeutic modalities.

* Familiarity with companion diagnostic development and associated regulatory considerations.

* Experience working across multiple programs or disease areas.

* Experience mentoring or providing scientific direction to other scientists.

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

Preferred Skills:

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