BioAnalytical Sciences (BAS) develops implements and provides strategic direction for state of the art bioanalytical methods and automation systems. BAS data and expertise enable the characterization of the pharmacokinetic, immunogenic and in vitro biological activities of biotherapeutics during drug development and throughout the product life cycle.
The BioAnalytical Manager (BAM) is a project management role in BAS. BAM works with clinical study teams, contracting group, data group, DMPK, BAS, central labs and contract labs to outsource and manage biosample (PK/ATA) analysis. The BAM is simultaneously assigned to multiple studies and is an agenda-driven ad-hoc member of the clinical study management team (SMT) for each study.
The responsibilities for BioAnalytical Manager include:
Driving the development of assay vendor SOWs, managing vendor contracts, including review of invoices, ensuring receipt of SOW deliverables, resolving or escalating issues where needed, and closing contracts
Assist with identifying and on-boarding assay vendors including SOW development, budget planning, and specifying data formats
Preparing vendor oversight plans for each study as needed. Ensuring alignment with cross-functional stakeholders and document team decisions in the PK/ATA Sample Flow Diagram
Developing timelines for PK and ATA data for managing contract labs to ensure samples are tested according to protocol/team timelines, data is returned in the specified format, and all SOW specified deliverables are met
Overseeing shipping and receipt of biosamples from central labs to assay laboratories
Providing biosample metrics and status updates to teams as requested
Supporting clinical study teams (PET/SMT), pharmacology teams through attending appropriate meetings as needed
Serving as the on-going operational point of contact between internal gRED functions and assay vendors for communication regarding sample logistics and availability, batching and testing timelines, reanalysis, and data reportable tracking
Making arrangement for samples and data handling/archiving at the completion of the study
Bachelor’s degree or Master’s degree in a scientific discipline
5 + years of experience in related field that includes experience working in the biotech industry and in clinical study teams with involvement in the processing and/or analysis of biological samples
Ability to deliver results successfully, collaborating with multi-cultural and geographically diverse teams
Technical experience/knowledge of bioanalytical assay methods.
Ability to work in a highly matrixed organization in a positive and collaborative manner
Strong organizational skills with attention to details
Independently manage multiple competing priorities, while working on multiple projects simultaneously
Excellent communication and presentation skills and effective influencing/negotiating skills.