MSD
Senior Principal Scientist, Oncology Translational Science and Clinical Biomarke
MSD, South San Francisco, California, us, 94083
Overview
Senior Principal Scientist (Sr Director), Oncology Translational Science and Clinical Biomarkers : Our Company’s Oncology organization is dedicated to delivering breakthrough innovations that extend and improve the lives of cancer patients worldwide. The team supports accessibility to medicine, provides new therapeutic procedures, and collaborates with governments and payers to ensure access to medicines. The focus is on innovation and launch execution excellence; we translate breakthrough science into innovative medicines that help people with cancer across the globe. This role is in translational research and biomarker development for Oncology programs. Working with early- and/or late-stage clinical development teams, the role will drive translational research and clinical biomarker development for critical oncology clinical programs. This role reports to the Head of Translational Oncology. The individual will be a key member in a dynamic, cross-functional environment, working with multiple functional line functions in various scientific and operational aspects of translational research and biomarker development. The role involves collaboration with ADTs, early- and late-stage clinical development teams, Oncology discovery and other translational groups; the BMx leads will develop program-specific clinical biomarker strategy by incorporating insight from discovery biology, clinical development, diagnostics, bioinformatics, molecular assay experts, quantitative modeling and biostats. Key Responsibilities Identify asset-specific translational deliverables & gaps. Build testable hypotheses and form BMx strategy: collaborate across different line functions to formulate testable clinical and translational hypotheses; and develop clinical biomarker and translational research strategy to test the hypothesis. Alignment, risk mitigation & strategy implementation: align with asset development team strategy. Build scientific insight to identify gaps and risks, proactively develop mitigation plans. Work with matrixed stakeholders to ensure implementation. Collaborate with Asset Development Teams, Early Development Teams, Product Development Teams, Clinical Trial Teams, Discovery, Informatics; Diagnostics, quantitative modeling team; Biostats, Molecular Assay teams, and other key line functions to author protocol-specific biomarker plans and ensure their efficient implementation. Incorporate cutting-edge scientific and technical advances to support clinical developments. Proactively identify and engage external key opinion leaders on specific hypothesis-driven collaborations to complement internal effort. Drive the publication of biomarker and translational research for respective studies. Analysis, interpretation & impact: collaborate with line functions to build formal analysis plans, participate in data analysis and interpretation. Effectively communicate the study plan, updates and outputs across function areas for optimal impact on projects. Contribute to Health Authority engagements; Registrational Efforts and Post Marketing Commitments. Hypothesis-building & strategy forming: collaborate with stakeholders in clinical development teams to formulate testable clinical hypotheses and develop clinical biomarker and translational research strategy to test the hypothesis. Alignment, risk mitigation & strategy implementation: align development team strategy with broader portfolio strategy. Build scientific insight to identify gaps and risks, proactively develop mitigation plans. Work with matrixed stakeholders to ensure implementation. Analysis, interpretation & impact: collaborate with line function experts to build formal analysis plans, participate in data analysis and interpretation. Communicate the study plan and outputs across function areas for optimal impact on projects. Note:
This role is available in Rahway, NJ; West Point, PA; Upper Gwynedd, PA; South San Francisco, CA or Boston, MA based on candidate preference. Qualifications PH.D., M.D. or M.D./Ph.D. with a minimum of 10 years of experience in oncology biomarker studies and translational clinical research Required Experience and Skills Experience in clinical trial development and execution; clear strategic view on the translational needs in clinical studies; experience & familiarity with experimental and bioinformatic aspects of translational research and biomarker development Ability to demonstrate a broad understanding of the end-to-end drug and diagnostic development process, and specific expertise in oncology, preferably immuno-oncology Possess communication and analytical skills to regularly interface with a wide variety of stakeholders within the organization, as well as with external clinicians and scientists Track record in cross-functional, highly matrixed collaborative groups on drug discovery and/or clinical development Strong interpersonal skills, as well as the ability to function in a team environment A proven track record in biomedical research Demonstrated record of scientific scholarship and achievement Preferred Experience and Skills Prior drug discovery experience in oncology Prior experience in communication with health authorities Specific expertise in immunology and/or immuno-oncology Experience in companion diagnostics development Project experience in biomarker discovery, biomarker and diagnostic development, and early or late drug development is desired. Eligible for ERP Required Skills Biomarker Development, Biomarker Research, Clinical Development, Clinical Research, Diagnostics Development, Drug Development, Immuno-Oncology, Oncology, Oncology Research, Risk Mitigation, Strategy Development, Translational Medicine, Translational Research Preferred Skills Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please note if you need an accommodation during the application or hiring process. 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 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 colleagues to respectfully challenge one another’s thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work schedule of three on-site days per week, with Friday remote, unless business needs require on-site presence. This guidance does not apply to field-based, facility-based, manufacturing-based, or research-based positions located at a company site; positions covered by a union agreement (if applicable); or any position where remote work is not reasonably feasible. This model also does not apply to roles designated as “remote”. The salary range for this role is $206,200.00 - $324,600.00 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 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. 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. 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. Search Firm Representatives Please Read Carefully. Merck & Co., Inc. 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:
01/31/2026 *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.
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Senior Principal Scientist (Sr Director), Oncology Translational Science and Clinical Biomarkers : Our Company’s Oncology organization is dedicated to delivering breakthrough innovations that extend and improve the lives of cancer patients worldwide. The team supports accessibility to medicine, provides new therapeutic procedures, and collaborates with governments and payers to ensure access to medicines. The focus is on innovation and launch execution excellence; we translate breakthrough science into innovative medicines that help people with cancer across the globe. This role is in translational research and biomarker development for Oncology programs. Working with early- and/or late-stage clinical development teams, the role will drive translational research and clinical biomarker development for critical oncology clinical programs. This role reports to the Head of Translational Oncology. The individual will be a key member in a dynamic, cross-functional environment, working with multiple functional line functions in various scientific and operational aspects of translational research and biomarker development. The role involves collaboration with ADTs, early- and late-stage clinical development teams, Oncology discovery and other translational groups; the BMx leads will develop program-specific clinical biomarker strategy by incorporating insight from discovery biology, clinical development, diagnostics, bioinformatics, molecular assay experts, quantitative modeling and biostats. Key Responsibilities Identify asset-specific translational deliverables & gaps. Build testable hypotheses and form BMx strategy: collaborate across different line functions to formulate testable clinical and translational hypotheses; and develop clinical biomarker and translational research strategy to test the hypothesis. Alignment, risk mitigation & strategy implementation: align with asset development team strategy. Build scientific insight to identify gaps and risks, proactively develop mitigation plans. Work with matrixed stakeholders to ensure implementation. Collaborate with Asset Development Teams, Early Development Teams, Product Development Teams, Clinical Trial Teams, Discovery, Informatics; Diagnostics, quantitative modeling team; Biostats, Molecular Assay teams, and other key line functions to author protocol-specific biomarker plans and ensure their efficient implementation. Incorporate cutting-edge scientific and technical advances to support clinical developments. Proactively identify and engage external key opinion leaders on specific hypothesis-driven collaborations to complement internal effort. Drive the publication of biomarker and translational research for respective studies. Analysis, interpretation & impact: collaborate with line functions to build formal analysis plans, participate in data analysis and interpretation. Effectively communicate the study plan, updates and outputs across function areas for optimal impact on projects. Contribute to Health Authority engagements; Registrational Efforts and Post Marketing Commitments. Hypothesis-building & strategy forming: collaborate with stakeholders in clinical development teams to formulate testable clinical hypotheses and develop clinical biomarker and translational research strategy to test the hypothesis. Alignment, risk mitigation & strategy implementation: align development team strategy with broader portfolio strategy. Build scientific insight to identify gaps and risks, proactively develop mitigation plans. Work with matrixed stakeholders to ensure implementation. Analysis, interpretation & impact: collaborate with line function experts to build formal analysis plans, participate in data analysis and interpretation. Communicate the study plan and outputs across function areas for optimal impact on projects. Note:
This role is available in Rahway, NJ; West Point, PA; Upper Gwynedd, PA; South San Francisco, CA or Boston, MA based on candidate preference. Qualifications PH.D., M.D. or M.D./Ph.D. with a minimum of 10 years of experience in oncology biomarker studies and translational clinical research Required Experience and Skills Experience in clinical trial development and execution; clear strategic view on the translational needs in clinical studies; experience & familiarity with experimental and bioinformatic aspects of translational research and biomarker development Ability to demonstrate a broad understanding of the end-to-end drug and diagnostic development process, and specific expertise in oncology, preferably immuno-oncology Possess communication and analytical skills to regularly interface with a wide variety of stakeholders within the organization, as well as with external clinicians and scientists Track record in cross-functional, highly matrixed collaborative groups on drug discovery and/or clinical development Strong interpersonal skills, as well as the ability to function in a team environment A proven track record in biomedical research Demonstrated record of scientific scholarship and achievement Preferred Experience and Skills Prior drug discovery experience in oncology Prior experience in communication with health authorities Specific expertise in immunology and/or immuno-oncology Experience in companion diagnostics development Project experience in biomarker discovery, biomarker and diagnostic development, and early or late drug development is desired. Eligible for ERP Required Skills Biomarker Development, Biomarker Research, Clinical Development, Clinical Research, Diagnostics Development, Drug Development, Immuno-Oncology, Oncology, Oncology Research, Risk Mitigation, Strategy Development, Translational Medicine, Translational Research Preferred Skills Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please note if you need an accommodation during the application or hiring process. 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 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 colleagues to respectfully challenge one another’s thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work schedule of three on-site days per week, with Friday remote, unless business needs require on-site presence. This guidance does not apply to field-based, facility-based, manufacturing-based, or research-based positions located at a company site; positions covered by a union agreement (if applicable); or any position where remote work is not reasonably feasible. This model also does not apply to roles designated as “remote”. The salary range for this role is $206,200.00 - $324,600.00 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 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. 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. 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. Search Firm Representatives Please Read Carefully. Merck & Co., Inc. 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:
01/31/2026 *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.
#J-18808-Ljbffr