Translational Biomarker Lead, Oncology & Hematology

Merck & Co.; Rahway (NJ); Hybrid; USD 191,000 - 300,000; Full time

Job summary

Merck & Co. in Rahway, NJ seeks a Principal Scientist to lead biomarker strategies across oncology and hematology programs from early to late clinical development.

You will design, implement, and communicate translational biomarker plans that tie to mechanism of action and clinical endpoints, guiding go/no-go decisions and patient selection. The role requires translating biology into clear hypotheses, leading cross-functional teams, and delivering high-value, interpretable evidence to inform

Qualifications

• 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 mechanism of action, disease biology, molecular heterogeneity, pharmacology, biomarkers, clinical endpoints, and development strategy.
• Experience with one or more 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.

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.

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

Education

Ph.D./M.D.

Tools

NGS

ctDNA

MRD

Immunohistochemistry

Flow Cytometry

Gene-expression profiling

Proteomics

Job description

Merck & Co. in Rahway, NJ seeks a Principal Scientist to lead biomarker strategies across oncology and hematology programs from early to late clinical development.

You will design, implement, and communicate translational biomarker plans that tie to mechanism of action and clinical endpoints, guiding go/no-go decisions and patient selection. The role requires translating biology into clear hypotheses, leading cross-functional teams, and delivering high-value, interpretable evidence to inform