Senior Scientist, Translational Oncology

Johnson & Johnson Innovative Medicine•Spring House, PA

1d•Onsite

About The Position

We are seeking a Sr. Scientist Clinical Assay Development to join the Oncology Translational Research (TR) organization in Spring House, PA. As a key member of the Clinical Assay Development Group, the successful candidate will lead the design, development, optimization, qualification, and troubleshooting of molecular and protein-based assays in support of oncology clinical programs. The candidate will partner closely with translational scientists, biomarker and diagnostic leads, computational biologists, data management, and clinical operations teams to enable biomarker-driven decision-making across multiple stages of drug development. The successful candidate will bring deep hands-on expertise in molecular and immunoassay technologies, a strong understanding of clinical assay development processes, and the ability to operate effectively across multiple programs in a fast-paced, matrixed environment.

Requirements

Master's degree in Biology, Molecular Biology, Biochemistry, Immunology, or a related life sciences discipline.
A minimum of 10 years of relevant experience in the pharmaceutical or biotechnology industry, with a substantial focus on molecular assay development and clinical biomarker support.
Extensive hands-on experience with nucleic acid extraction, qPCR, next-generation sequencing (NGS), single-cell analysis technologies, and immunoassay platforms such as ELISA and Meso Scale Discovery (MSD).
Demonstrated experience with tissue culture techniques and cell-based assay systems.
Strong understanding of clinical assay development processes, including method development, analytical qualification and validation, and transfer to external laboratories.
Proven ability to troubleshoot and independently resolve complex assay development challenges.
Demonstrated ability to manage multiple projects and competing priorities in a fast-paced, matrixed environment.
Excellent written and verbal communication skills, including the ability to clearly present scientific data to diverse audiences.
Strong attention to detail and analytical rigor across experimental design, data analysis, and the authoring and review of validation reports.
Strong interpersonal skills and a collaborative approach to problem-solving.

Nice To Haves

Direct experience supporting oncology clinical trials with translational biomarker strategies.
Familiarity with regulatory requirements and quality standards applicable to clinical assay development (e.g., CLIA, CAP, GCP).
Expertise in additional molecular platforms such as digital PCR, RNA sequencing, or spatial transcriptomics.
Experience with complex data analysis using bioinformatics tools.
Experience with assay automation and high-throughput workflows.

Responsibilities

Partner with translational research scientists, biomarker leads, and clinical operations teams to define assay strategies that support exploratory, predictive, and prognostic biomarker endpoints in oncology clinical trials.
Design, develop, optimize, and qualify molecular and immunoassay-based clinical assays using technologies such as qPCR, next-generation sequencing (NGS), single-cell analysis platforms, ELISA, and Meso Scale Discovery (MSD).
Provide hands-on technical leadership in the execution and troubleshooting of complex analytical workflows, and perform sample analysis in the Spring House laboratories as needed.
Support tissue culture and cell-based functional assay activities to complement translational biomarker strategies.
Manage and prioritize assay development activities across multiple oncology programs in parallel, ensuring timely delivery of high-quality data to support clinical decision-making.
Analyze and interpret complex datasets generated from molecular and immunoassay platforms, and prepare clear, accurate reports and presentations for internal stakeholders and cross-functional teams.
Review analytical protocols, reports, and raw data generated by team members to ensure compliance with internal standards and specifications.
Maintain rigorous documentation in accordance with Good Laboratory Practices, including sample management, ELN entries, and end-to-end traceability of raw and analyzed data, in line with company SOPs and regulatory requirements.
Evaluate and help adopt emerging assay technologies and platforms to strengthen the clinical assay development portfolio.
Present research findings and assay development updates at team meetings, departmental seminars, and leadership reviews.