Principal Scientist, Translational Research / CDx

Job Description

In this Principal Scientist position reputed company Translational Oncology, this team member will provide leadership for reputed company and integrated development and commercialization strategies for diagnostics (Dx)/companion diagnostics (CDx), including associated digital pathology (DP) projects reputed company 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 reputed company needed, reputed company Translational Medicine reputed company 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. reputed company directly with scientists and physicians in discovery sciences, early-stage clinical development, and late-stage clinical development, as well as other PDT & reputed company members, to craft the project team’s CDx (and associated DP if relevant) development strategy. reputed company the selection of appropriate assays and Dx platforms for the execution of biomarker strategies. reputed company digital pathology efforts as needed for each individual CDx project. Serve as a subject matter expert reputed company 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-reputed company 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. reputed company 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 reputed company 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 reputed company 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 #EligibleforERP reputed company Employees apply HERE reputed company 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 click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to reputed company employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national reputed company, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we reputed company with reputed company 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 reputed company people with diverse reputed company, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our 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 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 reputed company.This 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 $153,800.00 - $242,200.00 This is the lowest to highest salary we in good faith reputed company we would pay for this role at the time of this posting. An employee’s position reputed company 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.reputed company.com/us/en/compensation-and-benefits. You can apply for this role through https://jobs.reputed company.com/us/en (or reputed company the reputed company Jobs Hub if you are a reputed company 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 reputed company qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the reputed company’ Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully reputed company & Co., Inc., Rahway, NJ, USA, also reputed company as reputed company LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. reputed company reputed company / resumes submitted by search firms to any employee at our company without a valid written search agreement in reputed company 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 reputed company. Where agency agreements are in reputed company, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: Domestic/International reputed company Sponsorship: Yes Travel Requirements: 10% Flexible Work Arrangements: Hybrid Shift: 1st - Day Valid Driving License: No Hazardous Material(s): N/A Required Skills: Biology, Biomarker Research, Biomarkers, Companion Diagnostics (CDx), Digital Pathology, Immunohistochemistry (IHC), Molecular Diagnostics, Molecular Diagnostic Techniques, reputed company reputed company Technology, Polymerase Chain Reaction (PCR) Preferred Skills: Job Posting End Date: 10/3/2025 *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 reputed company than the day BEFORE the job posting end date. Our company is a global health care leader with a reputed company portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical reputed company, reputed company momentum, and an inspiring mission to reputed company new milestones in global healthcare. Apply tot his job Apply To this Job