MSD
Principal Scientist, Translational Research / CDx
MSD, North Wales, Pennsylvania, United States
Overview
Principal Scientist position within Translational Oncology responsible for leadership of aligned and integrated development and commercialization strategies for diagnostics (Dx)/companion diagnostics (CDx), including digital pathology (DP) projects when applicable. Responsibilities include execution of these strategies in collaboration with Product Development Teams (PDTs), Asset Development Teams (ADTs) and diagnostic partners. Position reports to Senior Principal Scientist, CDx. Primary Responsibilities
Direct CDx/IVD development projects, including associated DP efforts when needed, within Translational Medicine Lead cross-functional CDx (and where relevant, DP) development teams for various assets/biomarkers to drive the implementation of Dx projects and coordinate work with external Dx partners Interface with scientists and physicians in discovery sciences, early-stage clinical development, and late-stage clinical development, as well as other PDT & ADT members, to craft the project team’s CDx (and associated DP if relevant) development strategy Lead the selection of appropriate assays and Dx platforms for execution of biomarker strategies Lead digital pathology efforts as needed for each individual CDx project Serve as a subject matter expert collaborating with project teams, biomarker leads, clinical operations, and regulatory affairs on the implementation of global CDx assay strategies in global clinical trials Participate in preparation of Dx-related regulatory documents including pre-submissions, briefing books, IDEs, IVDR PSAs, PMAs Participate in meetings with global regulatory agencies to provide CDx expertise Provide CDx input into early-stage oncology programs Assist in the transfer of assays from in-house efforts to in vitro Dx companies Provide CDx expertise/assessment for due diligence teams Evaluate relevant new technologies including possible design/execution of pilot studies with Dx vendors Perform operational tasks required to execute assigned projects as needed, e.g. ordering samples, QC of incoming clinical trial biomarker results, assay/data transfer troubleshooting, etc NOTE: This role is available in Rahway, NJ; North Wales, PA or Boston, MA based on candidate preference. Qualifications
Education
Ph.D., M.D. or M.D./Ph.D. in biological sciences, life sciences or related field and five (5) years of experience in industry (pharmaceutical or companion diagnostics) Required Experience and Skills
Extensive experience with one or more major molecular biomarker platforms (i.e. NGS, IHC, PCR) Knowledge of the discovery, development, and application of molecular biomarkers in support of decision making for drug development and as CDx Demonstrated track record in the development of CDx Demonstrated expertise in molecular diagnostic development as evident by peer review publication record, patents, and/or products Experience influencing without direct authority, navigating complex or matrix organizations and successfully networking and forming partnerships with cross-functional teams Proven decision-making and planning skills High level of verbal and written communication skills including presentation capabilities to senior executives Preferred Experience and Skills
Eight or more years of experience in industry, preferably in both pharma and Dx settings Experience in development of digital pathology algorithms/assays Experience with requirements for EU IVDR, China HGRAC, JPMA, and other global markets for CDx development/registration Experience directly interfacing in meetings and written documents with global health authorities Deep technical knowledge in areas such as circulating tumor DNA (ctDNA), immunohistochemistry/pathology, digital pathology EEO and Accessibility
We are an Equal Employment Opportunity Employer and provide equal opportunities to all employees and applicants. We comply with applicable laws and encourage candidates to request accommodations during the application process if needed. Location
Rahway, NJ; North Wales, PA or Boston, MA based on candidate preference. US and Puerto Rico Residents Only:
Our company is committed to inclusion and provides accommodations during the hiring process upon request. Hybrid Work Model
U.S. employees in office-based roles will follow a Hybrid work model consisting of three on-site days per week with Friday remote, unless business needs require on-site work. Some roles may be remote. Salary Information
The salary range for this role is $153,800.00 - $242,200.00. Final compensation will depend on factors including education, experience, location, and business needs. Benefits and How to Apply
We offer a comprehensive benefits package. More information at the compensation and benefits page. Applications can be submitted through the company careers portal. Other Information
Travel up to 10%. Job posting end date: 10/03/2025. A notice about posting end date is included for applicant awareness.
#J-18808-Ljbffr
Principal Scientist position within Translational Oncology responsible for leadership of aligned and integrated development and commercialization strategies for diagnostics (Dx)/companion diagnostics (CDx), including digital pathology (DP) projects when applicable. Responsibilities include execution of these strategies in collaboration with Product Development Teams (PDTs), Asset Development Teams (ADTs) and diagnostic partners. Position reports to Senior Principal Scientist, CDx. Primary Responsibilities
Direct CDx/IVD development projects, including associated DP efforts when needed, within Translational Medicine Lead cross-functional CDx (and where relevant, DP) development teams for various assets/biomarkers to drive the implementation of Dx projects and coordinate work with external Dx partners Interface with scientists and physicians in discovery sciences, early-stage clinical development, and late-stage clinical development, as well as other PDT & ADT members, to craft the project team’s CDx (and associated DP if relevant) development strategy Lead the selection of appropriate assays and Dx platforms for execution of biomarker strategies Lead digital pathology efforts as needed for each individual CDx project Serve as a subject matter expert collaborating with project teams, biomarker leads, clinical operations, and regulatory affairs on the implementation of global CDx assay strategies in global clinical trials Participate in preparation of Dx-related regulatory documents including pre-submissions, briefing books, IDEs, IVDR PSAs, PMAs Participate in meetings with global regulatory agencies to provide CDx expertise Provide CDx input into early-stage oncology programs Assist in the transfer of assays from in-house efforts to in vitro Dx companies Provide CDx expertise/assessment for due diligence teams Evaluate relevant new technologies including possible design/execution of pilot studies with Dx vendors Perform operational tasks required to execute assigned projects as needed, e.g. ordering samples, QC of incoming clinical trial biomarker results, assay/data transfer troubleshooting, etc NOTE: This role is available in Rahway, NJ; North Wales, PA or Boston, MA based on candidate preference. Qualifications
Education
Ph.D., M.D. or M.D./Ph.D. in biological sciences, life sciences or related field and five (5) years of experience in industry (pharmaceutical or companion diagnostics) Required Experience and Skills
Extensive experience with one or more major molecular biomarker platforms (i.e. NGS, IHC, PCR) Knowledge of the discovery, development, and application of molecular biomarkers in support of decision making for drug development and as CDx Demonstrated track record in the development of CDx Demonstrated expertise in molecular diagnostic development as evident by peer review publication record, patents, and/or products Experience influencing without direct authority, navigating complex or matrix organizations and successfully networking and forming partnerships with cross-functional teams Proven decision-making and planning skills High level of verbal and written communication skills including presentation capabilities to senior executives Preferred Experience and Skills
Eight or more years of experience in industry, preferably in both pharma and Dx settings Experience in development of digital pathology algorithms/assays Experience with requirements for EU IVDR, China HGRAC, JPMA, and other global markets for CDx development/registration Experience directly interfacing in meetings and written documents with global health authorities Deep technical knowledge in areas such as circulating tumor DNA (ctDNA), immunohistochemistry/pathology, digital pathology EEO and Accessibility
We are an Equal Employment Opportunity Employer and provide equal opportunities to all employees and applicants. We comply with applicable laws and encourage candidates to request accommodations during the application process if needed. Location
Rahway, NJ; North Wales, PA or Boston, MA based on candidate preference. US and Puerto Rico Residents Only:
Our company is committed to inclusion and provides accommodations during the hiring process upon request. Hybrid Work Model
U.S. employees in office-based roles will follow a Hybrid work model consisting of three on-site days per week with Friday remote, unless business needs require on-site work. Some roles may be remote. Salary Information
The salary range for this role is $153,800.00 - $242,200.00. Final compensation will depend on factors including education, experience, location, and business needs. Benefits and How to Apply
We offer a comprehensive benefits package. More information at the compensation and benefits page. Applications can be submitted through the company careers portal. Other Information
Travel up to 10%. Job posting end date: 10/03/2025. A notice about posting end date is included for applicant awareness.
#J-18808-Ljbffr