Biosample Management Specialist
Harpoon Therapeutics (ticker: HARP) is a clinical-stage immunotherapy company developing a novel class of T cell engagers that harness the power of the body’s immune system to treat patients suffering from cancer and other diseases. T cell engagers are engineered proteins that direct a patient’s own T cells to kill target cells that express specific proteins, or antigens, carried by the target cells. Using its proprietary Tri-specific T cell Activating Construct (TriTAC®) platform, Harpoon is developing a pipeline of novel TriTACs initially focused on the treatment of solid tumors and hematologic malignancies. HPN424 targets PSMA and is in a Phase 1/2a trial for metastatic castration-resistant prostate cancer. HPN536 targets mesothelin and is in a Phase 1/2a trial for cancers expressing mesothelin, initially focused on ovarian and pancreatic cancers. HPN217 targets BCMA and is in a Phase 1/2 trial for relapsed, refractory multiple myeloma. HPN328 targets DLL3 and is in a Phase 1/2 trial for cancers expressing DLL3, initially focused on small cell lung cancer and other tumors with high-grade neuroendocrine features. Harpoon is led by an experienced management team. The company emphasizes a collegial, collaborative environment and has a strong record of scientific innovation, pioneering protein engineering, expertise in tumor immunology and pre-clinical and clinical research. For additional information about Harpoon Therapeutics, please visit www.harpoontx.com.
With multiple programs in clinical trials, we are seeking a highly motivated individual to manage clinical sample operations, ensuring robust and efficient sample shipment, sample testing and data reporting. The successful individual will be a member of Harpoon’s Translation Medicine group and will play an essential role in organizing complex clinical sample management processes across multiple clinical programs. Areas of responsibility include coordination between the central biorepository lab, CROs and study teams, alignment of clinical sample management activities with individual program and corporate goals.
- Serving as the on-going operational point of contact between clinical study team and assay vendors for communication regarding sample logistics and availability, batching and testing timelines, reanalysis, and data reporting.
- Developing timelines for managing contract labs to ensure samples are tested according to protocol and team timelines, data is returned in the specified format, and all SOW specified deliverables are met.
- Overseeing shipping and receipt of patient samples from central labs to assay laboratories.
- Identify sample discrepancies and missing samples, request queries, track queries and assist in query resolution.
- Provide sample shipment and analysis metrics and status updates to product development teams.
- Maintain sample and data repository. Support sample analysis data transfer, data reconciliation and data review.
- Making arrangement for samples and data handling/archiving at the completion of the study.
SKILLS AND QUALIFICATIONS
- Bachelor’s degree in a scientific discipline.
- 2+ years of experience in related field that includes experience working in the biotech industry and/or in clinical study teams with involvement in the processing and/or analysis of biological samples.
- Proficiency in MS office including Word, Excel, PowerPoint; knowledge in data analysis tools, e.g., Spotfire and database software is a plus.
- Effective team player and ability to collaborate with cross functional teams.
- Strong organizational skills with attention to details
- Independently manage multiple competing priorities, while working on multiple projects simultaneously.
- Excellent verbal and written communication, strong organizational and interpersonal skills.
- Ability to work in a dynamic, fast-paced, timeline-based environment.
- Knowledge in FDA & ICH/GCP regulations and guidelines and technical experience in bioanalytical assay methods are major pluses.