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 our hematology portfolio, with a particular focus on chronic myeloid leukemia (CML), BCR::ABL1-driven disease, and other myeloid malignancies.

This role will lead the development, execution, interpretation, and communication of translational and clinical biomarker strategies across programs spanning early through late clinical development, including targeted therapies and emerging therapeutic modalities.

The successful candidate will bring a strong understanding of hematologic disease biology, molecular drivers, clonal evolution, treatment response, and resistance mechanisms. They will translate these insights into decision-centric biomarker strategies that inform clinical development, including patient selection, dose and regimen optimization, molecular response assessment, resistance characterization, and differentiation from existing therapies.

Biomarker strategies should prioritize generation of scientifically rigorous, interpretable, and actionable evidence that informs program decisions rather than data generation alone.

Key Responsibilities

Biomarker Strategy and Clinical Development

* 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.

Hematology Disease Biology and Molecular Biomarkers

* 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 coexisting 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.

Cross-Functional Leadership and Scientific Integration

* 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.

Qualifications

Education

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

Required Experience and Skills

* 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.

Preferred Experience and Skills

* 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.

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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The primary location for this posting is:

USA - Pennsylvania - North Wales (Upper Gwynedd)

Where required by law, the compensation range for this role is provided below.

The salary range for the primary location of this role is:

$190,800.00 - $300,300.00

This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits. Available benefits include 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. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits .

Additional location(s): Please note the salary range above applies to the Primary Location of the position. Where a role has other listed locations, different compensation guidelines may apply. You may find the salary ranges for additional locations below. If the salary range is not listed for the location you are applying to, our Talent Acquisition team will provide further information to you relevant to your location.

Additional location(s) Compensation Information:

San Francisco Residents Only:  We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only:  We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

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Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

Domestic

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Hybrid

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

N/A

Job Posting End Date:

11/13/2026 *A job posting is effective until 11:59:59PM on the day BEFORE  the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:R417644