Overview Principal Scientist position within Translational Oncology. Provides leadership for aligned and integrated development and commercialization strategies for diagnostics (Dx)/companion diagnostics (CDx), including related digital pathology (DP) projects when applicable, and execution of those strategies in collaboration with Product Development Teams (PDTs), Asset Development Teams (ADTs) and diagnostic partners. 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 executing biomarker strategies. Lead digital pathology efforts as needed for each CDx project. Serve as a subject matter expert, collaborating with project teams, biomarker leads, clinical operations, and regulatory affairs on global CDx assay strategies in 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 pilot studies with Dx vendors. Perform operational tasks required to execute assigned projects as needed (e.g., ordering samples, QC of biomarker results, assay/data transfer troubleshooting). 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 industry experience (pharmaceutical or companion diagnostics). Required Experience and Skills Extensive experience with one or more major molecular biomarker platforms (e.g., NGS, IHC, PCR). Knowledge of discovery, development, and application of molecular biomarkers for decision making in drug development and as CDx. Demonstrated track record in CDx development. Demonstrated expertise in molecular diagnostic development evidenced by peer-reviewed publications, patents, and/or products. Experience influencing without direct authority, navigating matrix organizations and partnering with cross-functional teams. Proven decision-making and planning skills. High level of verbal and written communication skills, including presentations to senior executives. Preferred Experience and Skills Eight or more years of industry experience, preferably in both pharma and Dx settings. Experience in development of digital pathology algorithms/assays. Experience with EU IVDR, China HGRAC, JPMA, and other global CDx requirements. Experience interfacing with global health authorities in meetings and documents. Deep technical knowledge in areas such as circulating tumor DNA (ctDNA), immunohistochemistry/pathology, digital pathology. US and Puerto Rico Residents Only: Our company is committed to inclusion. Please contact us for accommodations during the application process. As an Equal Employment Opportunity Employer, we provide equal opportunities 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 legally protected characteristics. We comply with affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under U.S. EEO laws, visit the EEOC Know Your Rights and EEOC GINA Supplement pages. U.S. Hybrid Work Model: Effective September 5, 2023, employees in office-based positions in the U.S. will follow a Hybrid model (three on-site days per week, with Friday remote), with exceptions for certain roles. Salary range: $153,800.00 - $242,200.00. The range reflects good-faith assumptions and factors including education, experience, location, and business needs. Eligible for annual bonus and long-term incentives, if applicable. Benefits include medical, dental, vision, retirement (401(k)), paid holidays, vacation, and sick days. More information at the compensation and benefits page. Application: Apply at the company careers site. The posting end date is 10/03/2025.

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