Location: Spring House, PA
Title: Bioanalytical Scientist
Duration: 24 Months+
The Clinical Team Bioanalytical (BA) Scientist Group serves as the Client responsible scientist for execution of study bioanalysis for assigned clinical programs. Serves as an individual contributor for: development of BA strategies and BA plans for all phases of clinical programs, oversight of study BA timings and data review. The position serves as a primary Client contact for interactions with internal functional teams (including Project Management, Trial Support and Laboratory Support) and clinical stakeholders [including Clinical Pharmacology and Pharmacometrics (CPP), clinical teams (CTs), cross-functional trial teams (CFTTs), Compound Development Teams (CDTs) and Chemistry, Manufacturing and Controls (CMC) teams] to ensure two-way communication of information necessary for delivering Clients regulatory submission-related projects. The position requires the use of experience in bioanalytical sciences to guide the formation of bioanalytical strategies and resolutions of project related BA issues. Technical leadership and project management requirements are below.
Clinical Team Bioanalytical Representative (Temp)
Serve as the subject matter expert on the science and process of study bioanalysis .
Accountable for documenting BA strategies (e.g. selection of analytes, desired assay attributes, applicable matrices, and validation strategies etc.) for all phases of clinical programs.
Accountable for documenting and communicating BA plans to clinical project teams.
Guide continuous validation strategies for product life cycle (e.g., for new indications, assay placement, combination studies, etc.)
Review and contribute to study protocol PK, target engagement, and immunogenicity sampling time points.
Educate stakeholders on rationale for BA strategies, assay design, and experimental progress (as appropriate).
Proactively communicate with clinical portfolio project leadership to ensure that operational and scientific needs of projects are met by team.
Contribute to centralized and streamlined communication tools and processes to enable consistency of communication and Client information sharing with project stakeholders.
Serve as single point of contact for Cross Functional Trial Teams (for internal work) or to the appropriate partner representatives for collaborative studies (for external work), Project Managers and Compound Development Team (CDT) for bioanalytical related questions, concerns, issues, timelines, etc.
Review all supply agreements, study protocols and regulatory submissions pertaining to sampling and bioanalytical test, central lab SOWs , Data Flow diagrams, and Laboratory Manuals.
Communicate overall strategy of the projects to others
May serve as the liaison between team members and senior leadership.