Biomarker Technical Expert

Pay range: 47-57/hr (depending on experience) Position Summary The primary responsibility of this role is to provide biomarker technical expertise and support to the Translational Science Lead (TSL) to ensure operational implementation and execution of translational science strategies in clinical trials which may include phase I, II and III studies. The BTE is responsible for all operational and logistical aspects of carrying out biomarker related activities to ensure timely and quality data delivery. Workload includes multiple projects in the area of oncology. The BTE will interface with the TSL and multiple functions throughout the company as well as external partners to support and facilitate biomarker activities including clinical trial startup, sample logistics, lab vendor management (including companion diagnostics partners), data management related support for data collection, transfer, reconciliation and reporting, document preparation, budget support, and more. Position Duties and Responsibilities Collaborate closely with TSL, Clinical Operations, Biostatistics/Bioinformatics, and data management teams to support and execute translational science strategies in clinical trials Develop and provide operational input into all study related documentation and processes, and ensure collection, delivery and analysis of biomarker samples in compliance with these documents as well as GCP/ICH Serve as a single point of contact for biomarker operations across functions, and with collaborators and CROs Work with data management for set-up and application of biomarker-relevant pages, coordination of biomarker data format and delivery timelines, data transfer specification setup, to ensure timely and efficient data delivery (data transfers, reconciliation, analysis, reports), mutual data transfers with Companion Diagnostics (CDx) partners for CDx regulatory submissions, if needed Lab vendor management including contracting, data QC and delivery timelines, data transfers and reporting Manage implementation and execution of clinical biomarker sample logistics and operations including site feasibility and training, sample management plan, lab manual, monitoring of proper delivery Provide real-time sample oversight and drive ongoing sample reconciliation to support selection of samples for analysis Support data analysis including processing of data files, curation and integration of datasets, generation of tables, figures and listings Requirements/Preferences Education Minimum Requirement: Bachelors Degree Education Preferred: Masters Degree Skills & Competency Requirements Bachelor’s degree with 5+ years pharmaceutical or biotechnology industry experience required Clinical laboratory experience including involvement in the processing and/or analysis of clinical samples Critical reasoning skills including identification and resolution of complex problems and detail oriented with the ability to work independently and manage multiple competing priorities Proven project leadership skills, ability to successfully achieve results within multi-cultural and geographically diverse teams Excellent oral/written communication skills Preferences Doctoral-level degree with 3+ years relevant experience and discipline or Master’s degree with 5+ years in a relevant experience and discipline preferred. Extensive pharmaceutical industry experience and in‑depth knowledge of clinical drug development and precision medicine. Project management skills including planning, organizational and time management skills. Global vendor management experience #J-18808-Ljbffr Planet Pharma Group