6698 BioAnalytical Manager IV
The BioAnalytical Manager (BAM) provides bioanalytical operational expertise to local and global clinical trial teams, implementing and executing bioanalytical strategies in all phases of extensive clinical drug development pipeline.
Serves as a single point of contact between scientific functions (BioAnalytical Sciences, Clinical Pharmacology, Drug Metabolism and Pharmacokinetics), Bioanalytical labs, and clinical trial teams. Ensures the timely and efficient delivery of all bioanalytical operational aspects for clinical trials in accordance with applicable quality and regulatory standards (e.g. ICH/GCP).
Works with bioanalytical scientific functions to provide input on PK/ADA deliverable timing, outsourcing budget estimate for bioanalysis, to ensure program needs are met.
Develops and maintains effective, collaborative relationships with study teams, scientific function key stakeholders, data groups, internal outsourcing contacts, and CROs (both bioanalytical CROs and Central Labs).
Harmonizes sample collection and handling instructions per bioanalytical strategies and assay requirements to ensure they are included in clinical site lab manual.
Facilitate resolution of sample and data discrepancies and disposition of samples throughout the study lifecycle.
Develops study-specific sample and data flows plans with stakeholders, manages timelines for bioanalytical labs, and ensures samples are tested according to protocol and data is transferred in the specified format per study team timelines.
Assists function with outside spend budget planning and management of actual spend (invoices, PO) for studies.
Through CRO Central Point of Contact (CPoC), manage CRO deliverables and performance, ensuring all deliverables are met per SOWs and study timelines. Provide inputs on CRO performance, escalating concerns as appropriate.
Applies relevant regulatory compliance and internal business standards in the performance of job responsibilities (e.g. eTMF, RACT, Maintenance of Study Tracking Documentation).
Education and Experience Requirements:
Bachelor’s degree or higher in biology, chemistry, or related scientific discipline.
Project management certification desirable.
8-11 years of professional experience in pharmaceutical or biotechnology industry that includes experience related to bioanalysis and sample handling, CRO management, and/or clinical development/operations.
Working knowledge of ICH GCP.
Highly effective verbal and written communication.
Ability to make sound decisions with limited information in a changing landscape, influence, and negotiate effectively, using appropriate judgement.
Highly motivated and proactive in performing work independently with a problem-solving mindset.
Demonstrated evidence of successful collaboration and delivery of results in a highly matrixed organization, working with culturally and geographically diverse teams.
Excellent organization and project management skills with high attention to detail to independently manage multiple projects with competing priorities.