Specialist/Manager, Biosample Operations
Harpoon Therapeutics is a clinical-stage immunotherapy company located in South San Francisco. Harpoon Therapeutics 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. 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 small cell lung cancer and other DLL3-associated tumors. HPN536 targets mesothelin and is in a Phase 1/2a trial for cancers expressing mesothelin, initially focused on ovarian and pancreatic cancers. Harpoon has also developed a proprietary ProTriTAC™ platform, which applies a prodrug concept to its TriTAC platform to create a therapeutic T cell engager that remains inactive until it reaches the tumor. The company’s third proprietary technology platform, extended release TriTAC-XR, is designed to mitigate cytokine release syndrome. 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.
- Will be the point of contact and functional lead for all operational activities relating to vendor and sample management in order to deliver quality samples used in clinical studies.
- This role is an integral part of the study team during study startup, live phase and closeout. Ensures compliance with regulatory agency documentation and reporting requirements. Develops procedures and plans.
- 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. Provide sample shipment and analysis metrics and status updates to product development teams.
- Identify sample discrepancies and missing samples, request queries, track queries and assist in query resolution. Identifies stakeholders for questions impacting analysis and custody of samples and escalates issues to internal and external parties to ensure a timely resolution.
- 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.
- Working with clinical team to review and set up clinical documents, and ensure all stakeholders are involved for the review.
- Maintains professional demeanor when interacting with internal and external business partners
Skills and Qualifications
- Bachelor's is required, an advanced degree a plus. 5+ years of related experience with previous biosample management and vendor management is preferred.
- Possesses solid communications skills in order to efficiently and succinctly update the stakeholders on progress, questions and issues.
- Strong organizational skills with attention to details. Independently manage multiple competing priorities, while working on multiple projects simultaneously.
- Strong verbal and written communication, strong organizational and interpersonal skills.
- Ability to work effectively in a dynamic, fast-paced, timeline-based environment.
- Must be a self-starter and team player with strong interpersonal skills. Project management skills are a plus.
- Knowledge in FDA & ICH/GCP regulations and guidelines and technical experience in bioanalytical assay methods are major pluses.
- Proficiency in MS office including Word, Excel, PowerPoint; knowledge in data analysis tools.