Job Description
Our client a clinical-stage biopharmaceutical company focused on the development of novel antibody-drug conjugates and driven by the knowledge that patients are waiting for new treatment options. The consultant will work with CROs to develop and validate methods for PK and ADA sample analyses of ADC compounds, plan and manage PK/immunogenicity sample collection, shipment, storage and assay-related activities, interact with different partner CROs, and track relevant timelines for the ongoing clinical trials. The successful contractor would have experience working with CROs to develop and validate adequate methods (LC/MS or LBA) for PK and ADA sample analyses of ADC compounds, including assays for large molecule PK, small molecule PK, and ADA/nAb (including domain/epitope specificity testing).
Additional Responsibilities would include
- Preparing for BA related reports, contributing to BA related sections of clinical documents, and addressing BA related questions from HAs
Operational leadership of clinical bioanalytical studies and assays, being the primary point of contact with our partner CROs for all clinical Bioanalysis samples, liaising with these CROs for effective planning and operational conduct of the studies (e.g. sample bioanalysis plan, work order approval, laboratory manual development/review, bioanalytical sample management), and technical execution (e.g. sample collection, lab supply, data transfer and management, bioanalytical report and data QC) as needed - Provide input on CRO performance, escalating concerns as appropriate
- Defining, coordinating, managing, and overseeing the bioanalytical project timeline
- Operational oversight of clinical CRO partners, partnering with Quality Assurance to ensure the quality oversight of CRO partners
Background Desired
- Ph.D. in Biological Sciences, Chemistry, or equivalent, with 3+ years of related experience, M.S. with 8+ years of related experience
- Experience in bioanalytical method development, validation, and sample analysis in large molecules and small molecule analysis by LC-MS/MS and LBA required, experience with ADCs is preferred
- Experience either working in a CRO or managing at the outsourced work conducted by CROs
- Previous experience in a GLP, GCP, and/or CLIA compliant bioanalytical lab environment is required
- Experience in clinical trial operation including protocol review, laboratory manual development, sample collection/shipment/processing condition, and device/lab supply is required
Remote: Clinical Bioanalysis SME (233775)
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