Hispanic Alliance for Career Enhancement
Principal Scientist, Translational Research / CDx
Hispanic Alliance for Career Enhancement, Rahway, New Jersey, us, 07065
Overview
In this Principal Scientist position within Translational Oncology, this team member will provide leadership for aligned and integrated development and commercialization strategies for diagnostics (Dx)/companion diagnostics (CDx), including associated digital pathology (DP) projects when applicable, and execution of those strategies in collaboration with Product Development Teams (PDTs), Asset Development Teams (ADTs) and our 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 (including Regulatory, Commercial, Business Development, Project Management, Operations, Clinical Development, Statistics, Bioinformatics, Alliance Management, etc.) to drive the implementation of Dx projects and coordinate the work conducted with our external Dx partners. Interface directly 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 the execution of biomarker strategies. Lead digital pathology efforts as needed for each individual CDx project. Serve as a subject matter expert within our Company, 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, for example, 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 an area of interest such as circulating tumor DNA (ctDNA), immunohistochemistry / pathology, digital pathology Requisition and location notes:
This posting includes notes about eligibility and locations, and references to hybrid work arrangements and travel expectations in the U.S. Equal Employment Opportunity
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. Additional information
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 as described by company policy. The salary range for this role is $153,800.00 - $242,200.00. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. Benefits include medical, dental, vision, retirement, and paid time off; details are available at the company compensation and benefits page.
#J-18808-Ljbffr
In this Principal Scientist position within Translational Oncology, this team member will provide leadership for aligned and integrated development and commercialization strategies for diagnostics (Dx)/companion diagnostics (CDx), including associated digital pathology (DP) projects when applicable, and execution of those strategies in collaboration with Product Development Teams (PDTs), Asset Development Teams (ADTs) and our 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 (including Regulatory, Commercial, Business Development, Project Management, Operations, Clinical Development, Statistics, Bioinformatics, Alliance Management, etc.) to drive the implementation of Dx projects and coordinate the work conducted with our external Dx partners. Interface directly 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 the execution of biomarker strategies. Lead digital pathology efforts as needed for each individual CDx project. Serve as a subject matter expert within our Company, 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, for example, 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 an area of interest such as circulating tumor DNA (ctDNA), immunohistochemistry / pathology, digital pathology Requisition and location notes:
This posting includes notes about eligibility and locations, and references to hybrid work arrangements and travel expectations in the U.S. Equal Employment Opportunity
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. Additional information
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 as described by company policy. The salary range for this role is $153,800.00 - $242,200.00. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. Benefits include medical, dental, vision, retirement, and paid time off; details are available at the company compensation and benefits page.
#J-18808-Ljbffr