Biosample Associate I
Responsible for tracking and management of protocol-level samples and scans. Escalates to Clinical Pharmacology, Contracts Management, Medicinal Chemistry, Pharmacometrics, Protein Therapy, Research Biology and Toxicology as appropriate where there are areas of departure from established standards or recommended guidelines. This job contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs.
Uses professional concepts and company objectives to resolve issues of moderate scope in which analysis of situation or data requires a review of identifiable factors. Exercises judgement in within defined procedures and practices to determine appropriate action. Under direct supervision, executes on assigned tasks following appropriate laboratory/technical procedures. . Partners across the study team to ensure sample management needs are clearly understood and can be contracted in accordance with Nektar policy. Performs biomarker and pharmacokinetic/immunogenicity sample tracking using advanced Microsoft Excel skills: generating reports and trackers, collaborating with internal and external partners for clarification and escalation of issues to the research team. Performs tracking of images using advanced Microsoft Excel skills: generating reports and trackers, collaborating with internal and external partners for clarification and escalation of issues to the research team. Maintains sample and image collection instructions from Scientists to Vendor sites to ensure clarity, quality and compliance. Responsible for tracking and management of document versions aligned with protocols and amendments. Reviews laboratory and imaging manuals, associated forms and labels for proper collection techniques, time point requirements and sample/image handling to ensure viability and data reliability. Supports escalation of sample and imaging management concerns during the execution of the study. Ensures all issues are documented, advises on mitigation and remediation, escalates issues and drives to closure in support of team goals and timelines. Actively maintains status updates for routine reporting to study team. Demonstrates good communication and interpersonal skills; leverages those competencies to ensure continuous progress, moving issues to resolution. Displays advanced Microsoft Excel skills, strong written and oral communication skills. Works with all levels of staff and management to resolve issues and update on progress. Able to work with large an small teams to achieve business goals with professionalism and poise. Maintains current training requirements. Maintains compliance to company Environmental Health and Safety policies, procedures and practices.
A minimum of a Bachelors Degree is required. Equivalent experience may be accepted. 0-1 year of experience in research or drug development is preferred. Years at the undergraduate and graduate level may be substituted for years of required experience. Biological sample management including biomarkers, pharmacokinetics and/or immunogenicity in research or clinical trials preferred. Immunology/Immuno-Oncology experience preferred. Understanding of regulatory guidance for biological sample and imaging requirements, including considerations for patient privacy, protocol development and ICF preferred. Firsthand knowledge of laboratory or imaging/ECG operations highly desired. Basic understanding of data management. Demonstrable knowledge of sample tracking, issue escalation and resolution processes.
Demonstrated ability to analyze and interpret problems and data from a variety of sources.
Experience and fluency with MS Office tools (Word, Excel, PowerPoint, Project) highly desirable. Must be able to demonstrate proficiency in the creation and efficient navigation of Excel trackers. Demonstrated strengths in planning, organizational, analytical skills, time management, problem solving, and attention to detail. Ability to travel 10-15% of the time.
We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class. Nektar Therapeutics will consider for employment qualified applicants with criminal histories in the manner proscribed by the San Francisco Fair Chance Ordinance.