Principal Scientist, Clinical Trial Biomarkers/Clinical Genomics Full-time

Principal Scientist, Translational Molecular Biomarkers

Translational Molecular Biomarkers (TMB) is responsible for translating preclinical molecular biomarkers into clinical development across all therapeutic areas and all phases of clinical development at our Research & Development Division. TMB laboratories leverage a diverse array of technologies to develop biomarker assays to help confirm engagement of therapeutic targets and understand mechanisms of drug action and patient response.

The Genomics group within TMB is seeking a highly motivated and skilled candidate for a Principal Scientist position. This role is essential for developing, optimizing, and deploying biomarker assays to enable clinical development at our Company.

Key Responsibilities:

• Serve as a subject matter expert in Genomics assay development and fit-for-purpose analytical validation to enable biomarker testing in clinical trials across all therapeutic areas, including Oncology, Infectious Disease, Immunology, Neuroscience, Cardiometabolic and cardiorespiratory disease.
• Interface with Discovery scientists, Biomarker/Asset Leads and Clinical leads to develop genomic biomarker strategies and plan, execute, and interpret biomarker analyses to ensure accurate and meaningful conclusions.
• Interface with CROs to develop and analytically validate genetic biomarker assays to support clinical programs.
• Oversee and/or support results reporting and analysis of clinical samples, both internally and with external vendors in compliance with the relevant regulatory and quality standards.
• Apply advanced technical and scientific expertise to identify and evaluate new genomics technologies through internal and external R& D collaborations to enable innovative strategies for clinical trial biomarker testing.
• Author and review internal technical reports including sections of regulatory filings (e.g. IND, BLA) as needed and external scientific publications summarizing data and present findings to clinical and other internal and external stakeholders.

Position Qualifications:

Education Minimum Requirement:

• PhD or MD/PhD in a life sciences discipline (Genetics, Biology, Biochemistry, Immunology, Molecular Pathology, Medical Laboratory Sciences, Cell Biology, etc.) or Chemistry

Required Experience and Skills:

• 7+ years of pharmaceutical or related experience in clinical genomics testing, including at least 5 years of experience in molecular diagnostics, or translational research experience identifying predictive/prognostic genetic biomarkers. Experience in industry or academic-sponsored clinical/translational research
• Strong background in Genomics based assay development and analytical method validation with extensive knowledge and experience with regulated assays, standards, and guidelines pertaining to analytical method validation for clinical trial testing and FDA biomarker guidance
• Demonstrated experience with various NGS platforms, digital PCR, other molecular genetic approaches for somatic and germline variant identification and gene expression analyses from a variety of biological matrices in oncology and non-oncology settings
• Proven ability to effectively work independently within a matrixed organization, taking initiative to creatively and innovatively solve problems to enable clinical trial biomarker testing
• Strong record of scientific achievement (publications, patents, internal/external scientific/technical presentations, etc.)
• Strong interpersonal, verbal and written communication skills.

Preferred Experience and Skills:

• Broad knowledge of drug development process
• Experience with liquid biopsy testing (e.g. cfDNA, utDNA, cfDNA methylation, etc.)
• Experience with the use of minimal residual disease assays to support clinical studies
• Deep understanding of disease biology in Oncology and/or Immunology fields

Required Skills: Biomarker Assay Development, Biomarkers, Clinical Assays, Clinical Biomarkers, Clinical Chemistry, Clinical Development, Clinical Studies, Clinical Trials, Cross-Departmental Collaboration, Data Analysis, Drug Development, Immunology, Laboratory Sciences, Microbiology, Molecular Diagnostics, Next Generation Sequencing (NGS), Oncology, Pathology, Physiology, Regulatory Experience

Preferred Skills:

Salary Range: $153,800.00 – $242,200.00

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits, 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.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

Job Posting End Date: 11/7/2025

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