Synthekine is a Menlo Park, CA based biotechnology company focused on discovering and developing best in class cytokine therapeutics to treat cancer and autoimmunity. We use our unique insights on how cytokines bind to their receptors and tune these systems though protein engineering to generate therapeutics that have transformative potential. Synthekine was formed in 2019 and has raised $190M from leading biotech investors. We are advancing a deep pipeline of therapeutics against some of the most important cytokine targets. Come join us and help us give patients and physicians better options to treat disease and advance cytokine science along the way.
The Biospecimens Operations Associate / Specialist (BOA/S) will act as the SME for all biological samples collected during a clinical trial. We are seeking an experienced BOA/S to support translational and biomarker activities and function as the point of contact and functional lead for the central vendor and oversees all operations activities for sample management to deliver quality samples used in evaluating the drug efficacy. 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 May participate in vendor negotiations, product and software evaluations, implementations and management. May support both clinical and discovery samples. This job contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs.
- Lead all biosample management aspects of clinical studies in close collaboration and communication with the clinical study team
- Provide input to improve existing biorepository procedures and assist in development and implementation of standard operating procedures
- Manage outsourcing to external vendors/CROs of certain biosample related tasks for respective clinical studies as applicable (e.g. kit/supplies, shipping services, central labs, biomarker assay testing, etc.)
- Drive development of the scope of work (SOW) and budgets between Synthekine and vendors/CRO
- Create POs, review invoices and facilitate payments to external vendors/CROs for work performed
- Serve as the primary operational point of contact between Synthekine, clinical sites and/or external vendors/CROs for communication regarding biosample logistics (e.g., inventory/availability, discrepancy resolution, shipment planning, batching and testing timelines, analysis, re-analysis and data reporting)
- Manage sample transfers and/or shipments between clinical sites and Synthekine or vendor/CRO responsible for processing, storing and/or testing samples
- Maintain oversight over vendors/CROs from set-up to final deliverable to ensure management of biosamples is conducted in accordance with the protocol, SOW, specified timelines, budgets, data transfer specifications and associated clinical study goals
- Facilitate biosample kit design, selection/acquisition of tubes and other materials, development of test requisition form and associated instructions for use
- Review and contribute to development of any clinical study materials outlining operational aspects of biosample management (e.g., site training materials, processing/handling instructions and manuals)
- Maintain an organized database/inventory for tracking all biosamples and associated data for clinical studies to serve as a centralized resource
- Facilitate requests for sample analysis, data transfer, data reconciliation and data review.
- Take personal responsibility for ensuring high quality biosamples/data via all appropriate means.
- Regularly review and ensure alignment between biosample inventory, eCRF database and any other vendor/CROs documentation
- Responsible for ensuring proper patient informed consent prior to any assay testing being performed via quality checks on patient consent attribute log files and/or eCRFs
- Initiate timely reconciliation of any issues identified during inventory and/or quality review checks, including resolution of sample discrepancies and missing samples, through generation, tracking and close-out of queries
- Maintain adequate and detailed documentation associated with biosample management work and ensure proper filing in the eTMF as applicable, including clinical biomarker and PK/ADA assay testing documentation
- Assist Biosamples Operations Lead and Bioanalytical Operation Manager in preparation of audits and inspections, including retrieval of applicable documentation from vendors/CROs
- Generate reports and provide biosample management and analysis metrics/updates to clinical study, biomarker, and diagnostic teams
- Arrange for biosamples and data handling/archiving at the completion of the study.
- Life sciences degree (BS or MS) in Scientific, Medical, Healthcare, or related 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 biosamples.
Prior experience of working in teams running clinical studies is a plus
- Knowledge in FDA & ICH/GCP/GLP/GPP regulations and guidelines and technical experience in bioanalytical assay methods are major plus
- Prior experience in clinical biomarker operation and/or sample management is highly desirable.
- Ability to work in a dynamic, fast-paced, timeline-based environment.
- 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
- Excellent verbal and written communication.
Please apply at email@example.com.
Synthekine is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.