You will play a critical role in supporting clinical biomarker strategies in all stages of drug development and post marketing activities through scientific and technical leadership, oversight and management of external and internal partners involved in delivering quality, timely, and regulatory compliant biomarker analytical assays and data. You will have frequent interaction with Clinicians, Translational Medicine leads and colleagues in Global Clinical Pharmacology, Precision Medicine, Clinical Research Units, Contract Research Organizations (CROs), Finance, Procurement and external collaborators, as appropriate.
- Serves as a member of the clinical study team and biomarker bioanalytical subject matter expert for executing clinical study setup and conduct, contributing to the study protocol development and review, preparing submissions, addressing regulatory queries, developing and implementing bioanalytical strategies and assays, and delivering regulatory compliant data and reports within program timelines.
- Leads development of novel complex fit-for-purpose biomarker methodologies, troubleshooting and resolution of complex technical and logistical issues with vendors and study teams. Identifies technology/capabilities gaps and proposes mitigation strategies, including development of novel technical capabilities with vendors. Scientifically evaluates complex data (e.g., evaluates aberrant results and data trends), anticipates and corrects potential issues, and able to appropriately guide study teams through complex issues resolution.
- Leads and oversees fit-for-purpose biomarker assay lifecycle management from early stage to registration encompassing bioanalytical development and method design, validation, data quality review, corresponding sample analyses and reporting to meet evolving program objectives and regulatory expectations. Guides and leads study teams with respect to the selection and execution of the biomarker bioanalytical strategy.
- Functions as key point of contact with external and internal laboratories and leads selection, qualification, performance evaluation, periodic visits and audits of CRO laboratories conducting clinical biomarker assays.
- Supports the clinical trial conduct within scope of the Clinical Assay Group responsibilities, including development and review of documents and processes such as CRF and data setup, clinical site lab manual, sample management and reconciliation, bioanalytical study planning and reporting, budgeting and invoicing, compliance with clinical SOPs and policies, and regulatory inspection readiness and conduct.
- Contributes to the development of Best Practices processes, templates, and policies
- Maintains up-to-date knowledge of current and novel chromatographic/mass spectrometry and ligand binding (e.g., ELISA, ECL) technologies and techniques, global regulatory guidance's and expectations, and industry best practices.
- PhD in Biology, Biochemistry, Immunology, Analytical Chemistry/Chemistry with 3+ years with biomarker assay development experience, method validation and sample analyses using chromatographic/mass spectrometry and ligand binding (e.g., ELISA, ECL) methodologies. Master's degree with 5+ years OR Bachelor's degree with 7+ years.
- Subject matter expert experience in regulated bioanalysis and understanding of bioanalytical techniques commonly used for fit-for-purpose biomarker measurement.
- Demonstrated experience in and current understanding of disease biology and how it applies to biomarkers.
- Expertise in development, validation and troubleshooting of complex fit-for-purpose biomarker methods in various matrices (including tissue) using broad methodologies and more novel techniques such as hybrid LBA-LCMS for small and/or protein biomarker analysis & clinical sample analysis.
- Strong experience in and current understanding of critical reagent generation & lifecycle management.
- Good understanding of cell-based assays, flow cytometry, enzymatic and molecular assays.
- In depth knowledge and ability to provide interpretation of GxP, CAP and CLIA regulations governing conduct of clinical trials and regulatory guidances and expectations relevant to regulated bioanalysis.
- Highly effective communication skills: verbal, written, and presentation.
- CRO management and outsourcing experience.
- Understanding of clinical trial design, overall principles of clinical development, and related disciplines (e.g., clinical pharmacology, biology, formulation and drug product).
- Experience preparing regulatory submissions and addressing regulatory queries.
Relocation support available
Work Location Assignment:Flexible
Relocation assistance may be available based on business needs and/or eligibility.
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