MSD
Principal Scientist, Clinical Trial BiomarkersClinical Genomics
MSD, Rahway, New Jersey, us, 07065
Job Description
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 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 presenting findings to clinical and other 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, identifying predictive/prognostic genetic biomarkers, and experience in industry or academic-sponsored clinical/translational research.
Strong background in genomics-based assay development and analytical method validation with extensive knowledge of regulated assay standards and guidelines for clinical trial testing and FDA biomarker guidance.
Demonstrated experience with NGS platforms, digital PCR, and 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 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).
Strong interpersonal, verbal, and written communication skills.
Preferred Experience and Skills
Broad knowledge of the drug development process.
Experience with liquid biopsy testing (e.g., cfDNA, ctDNA, cfDNA methylation).
Experience with minimal residual disease assays to support clinical studies.
Deep understanding of disease biology in Oncology and/or Immunology fields.
Equal Employment Opportunity We provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. For more information about your rights under U.S. EEO laws, please visit EEOC Know Your Rights.
Benefits & Compensation Salary range: $153,800.00 – $242,200.00. The successful candidate will be eligible for annual bonus and long-term incentive if applicable. We offer a comprehensive package of benefits including medical, dental, vision, retirement (401(k)), paid holidays, vacation, and compassionate and sick days.
Work Arrangements Hybrid – three on‑site days per week with remote work options on Fridays.
Other Details
Travel: 10%
Relocation: Domestic
Visa Sponsorship: No
Employee Status: Regular
Job Posting End Date: 11/07/2025
Required Experience Staff IC (years experience: unspecified)
Key Skills Machine Learning, Python, Data Science, AI, R, Research Experience, Sensors, Drug Discovery, Research & Development, Natural Language Processing, Toxicology Experience.
Employment Type Full‑Time
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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 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 presenting findings to clinical and other 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, identifying predictive/prognostic genetic biomarkers, and experience in industry or academic-sponsored clinical/translational research.
Strong background in genomics-based assay development and analytical method validation with extensive knowledge of regulated assay standards and guidelines for clinical trial testing and FDA biomarker guidance.
Demonstrated experience with NGS platforms, digital PCR, and 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 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).
Strong interpersonal, verbal, and written communication skills.
Preferred Experience and Skills
Broad knowledge of the drug development process.
Experience with liquid biopsy testing (e.g., cfDNA, ctDNA, cfDNA methylation).
Experience with minimal residual disease assays to support clinical studies.
Deep understanding of disease biology in Oncology and/or Immunology fields.
Equal Employment Opportunity We provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. For more information about your rights under U.S. EEO laws, please visit EEOC Know Your Rights.
Benefits & Compensation Salary range: $153,800.00 – $242,200.00. The successful candidate will be eligible for annual bonus and long-term incentive if applicable. We offer a comprehensive package of benefits including medical, dental, vision, retirement (401(k)), paid holidays, vacation, and compassionate and sick days.
Work Arrangements Hybrid – three on‑site days per week with remote work options on Fridays.
Other Details
Travel: 10%
Relocation: Domestic
Visa Sponsorship: No
Employee Status: Regular
Job Posting End Date: 11/07/2025
Required Experience Staff IC (years experience: unspecified)
Key Skills Machine Learning, Python, Data Science, AI, R, Research Experience, Sensors, Drug Discovery, Research & Development, Natural Language Processing, Toxicology Experience.
Employment Type Full‑Time
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