Hope Changes Lives
As a member of the Translational Oncology, Translational Sciences group, you will play a critical role in executing Translational Oncology Biomarker strategies through scientific technical oversight and management of external and internal partners involved in the implementation of clinical trial biomarker sample analyses. You will bring expertise to the team in the areas of clinical assays development, validation, transfer and serve as a subject matter expert when interacting with vendors utilizing this platform. You will have strong working knowledge in platforms comprising genomics/transcriptomics, plate-based assays, flow cytometry and epigenetic modulation and would be considered as a subject matter expert in at least one of these platforms.
Serves as a member of the clinical study team and biomarker bioanalytical subject matter expert for executing clinical study setup & conduct, contributing to the study protocol development and review (schedule of assessments), developing and implementing bioanalytical strategies & assays, and delivering regulatory compliant data and reports within program timelines.
Supports the clinical trial conduct including development and review of documents and processes such as CRF and data setup, clinical site lab manual, analytical lab manuals, SRFs, sample management & reconciliation, bioanalytical study planning & reporting, budgeting & invoicing, compliance with clinical SOPs & policies, and regulatory inspection readiness & conduct.
Leads biomarker data management activities in support of early oncology clinical trial portfolio.
Leads development of novel complex fit-for-purpose biomarker next-generation platforms (e.g. scRNAseq, CiTEseq, ATACseq, mass cytometry, high dimensional spectral flow, high sensitivity cytokine profiling).
Troubleshooting & resolution of complex technical & logistical issues with vendors and study teams.
Functions as subject matter expert for at least one of the assay platforms mentioned above across the early stage oncology portfolio.
Provides bio-analytical assay and operational expertise to Study Teams to ensure delivery of high-quality clinical biomarker data.
Provides operational support to other Biomarker Clinical Assay Leads to ensure timely study start up and study close out activities.
Prepares and reviews bioanalytical reports: contributes to regulatory submissions and responds to regulatory queries when needed.
Functions as Key point of contact with internal labs, external vendors, and academic clinical laboratories, with oversight responsibilities for contracts, agreements, work plans, budget and invoices, assay transfer, assay validation, sample analyses, data transfers and overall data quality.
Provides technical support for selection, qualification and periodic audits of external laboratories supporting clinical trial biomarker assays.
Liaise with internal partners to ensure appropriate biomarker sample handling and processing steps are captured in clinical trial Laboratory Manual.
Contributes to the process improvement initiatives including but not limited to CAPA implementation and participation in clinical site training activities
PhD with 2+ years of relevant experience or M.S./B.S. with five years of industry or clinical laboratory experience in biomarker assay development, assay validation and implementation within clinical trials, employing a broad range of platform technologies (e.g. RNAseq, NanoString, NGS, IHC, PCR, FISH, flow cytometry, other cell based and circulating biomarker technologies).
Expertise in biomarker platforms assay establishment, troubleshooting, validation and sample analysis.
Demonstrated experience with clinical laboratory regulatory and compliance requirements, and hands-on knowledge of global regulatory requirements including GLP, GCP and the clinical trial process.
Assay problem solving and analytical skills; ability to resolve technical issues that may arise during method development, assay validation and sample analysis.
Demonstrated ability to think strategically and creatively while contributing to multiple projects.
Outstanding ability to work productively in a collaborative, multi-disciplinary/diverse team setting
Highly effective verbal and written communication skills.
Additional certification in Clinical Laboratory Sciences, experience in biomarker analyses and clinical laboratory testing in Oncology, Molecular Oncology, or Hematopathology.
Work Location Assignment: Flexible