EyeBio
Principal Scientist, Clinical Trial Biomarkers/Clinical Genomics
EyeBio, 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 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
Equal Employment Opportunity Employer
As an Equal Employment Opportunity Employer, 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. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit EEOC Know Your Rights or EEOC GINA Supplement.
We are proud to be a company that embraces the value of bringing together talented and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.
US and Puerto Rico 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.
Employee Status:
Regular
Relocation:
Domestic
VISA Sponsorship:
No
Travel Requirements:
10%
Flexible Work Arrangements:
Hybrid
Shift:
Not Indicated
Valid Driving License:
No
Hazardous Material(s):
n/a
Job Posting End Date:
11/7/2025
Salary:
$153,800.00 - $242,200.00
Annual bonus and long‑term incentive may be available. We offer a comprehensive package of benefits including medical, dental, vision, retirement benefits, paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.
Hybrid work model: Effective September 5, 2023, employees in office‑based positions in the U.S. will work a hybrid schedule with three on‑site days per week (Monday‑Thursday, with Friday remote) unless business needs require on‑site presence. This model does not apply to field‑based, facility‑based, manufacturing‑based, or research‑based positions located at a Company site, collective‑bargaining agreements, or positions requiring on‑site presence.
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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
Equal Employment Opportunity Employer
As an Equal Employment Opportunity Employer, 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. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit EEOC Know Your Rights or EEOC GINA Supplement.
We are proud to be a company that embraces the value of bringing together talented and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.
US and Puerto Rico 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.
Employee Status:
Regular
Relocation:
Domestic
VISA Sponsorship:
No
Travel Requirements:
10%
Flexible Work Arrangements:
Hybrid
Shift:
Not Indicated
Valid Driving License:
No
Hazardous Material(s):
n/a
Job Posting End Date:
11/7/2025
Salary:
$153,800.00 - $242,200.00
Annual bonus and long‑term incentive may be available. We offer a comprehensive package of benefits including medical, dental, vision, retirement benefits, paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.
Hybrid work model: Effective September 5, 2023, employees in office‑based positions in the U.S. will work a hybrid schedule with three on‑site days per week (Monday‑Thursday, with Friday remote) unless business needs require on‑site presence. This model does not apply to field‑based, facility‑based, manufacturing‑based, or research‑based positions located at a Company site, collective‑bargaining agreements, or positions requiring on‑site presence.
#J-18808-Ljbffr