Principal Scientist, Clinical Trial BiomarkersClinical Genomics

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

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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 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

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 anothers thinking and approach problems collectively.

Learn more about your rights including under California Colorado and other US State Acts

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Effective September 5 2023 employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week Monday - Thursday although the specific days may vary by site or organization with Friday designated as a remote-working day unless business critical tasks require an on-site Hybrid work model does not apply to and daily in-person attendance is required for field-based positions; facility-based manufacturing-based or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note this Hybrid work model guidance also does not apply to roles that have been designated as remote.

The salary range for this role is

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employees 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 can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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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