As a member of Clinical Bioanalytics within Translational Clinical Sciences, the Biologics & Immunogenicity Clinical Assay Lead will play a critical role in supporting clinical 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 PK, PD, and/or immunogenicity bioanalytical assays and data.
Reports to Biologics and Immunogenicity Group Lead or Small Molecule Clinical Assay Lead with supervisor responsibilities, Clinical Bioanalytics, within Translational Clinical Sciences.
Frequent interaction with colleagues in Translational Clinical Sciences, Clinical, Medicines or Biomedicines Design (PDM/BMD), Clinical Operations, Data Management, Statistics, Regulatory, and Finance, as appropriate.
Frequent interaction with bioanalytical Contract Research Organizations (CROs), Central Laboratories, and as appropriate external collaborators.
Member of Clinical sub-teams and study teams.
Serves as a member of the clinical study team and bioanalytical subject matter expert for executing clinical study setup & conduct, contributing to the study protocol development & review, preparing submissions, addressing regulatory queries, implementing bioanalytical strategies & assays, and delivering regulatory compliant data and reports within program timelines.
Leads and oversees large molecule PK, PD, and immunogenicity (ADA and Nab) assay lifecycle management from early stage to registration encompassing executing analytical strategy, development and method design, validation, data quality review, corresponding sample analyses & reporting to meet evolving program objectives and regulatory expectations. Assists CROs with effective troubleshooting of the bioanalytical assay and issue resolution.
Functions as key point of contact with external & internal laboratories and supports (or leads, as appropriate) selection, qualification, performance evaluation, and periodic visits and audits of CRO laboratories conducting clinical PK, PD and immunogenicity assays (as relevant to the role).
Supports the clinical trial conduct within scope of the Clinical Bioanalytics responsibilities, including development and review of documents and processes such as CRF and data setup, clinical site lab manual, sample management & reconciliation, bioanalytical study planning & reporting, budgeting & invoicing, compliance with clinical SOPs & policies, and regulatory inspection readiness & conduct.
Contributes to the development of Best Practices, processes, templates, and policies.
Maintains up-to-date knowledge of current and novel ligand binding technologies & techniques, global regulatory guidance & expectations, and industry best practices.
As appropriate, additional responsibilities may include the following:
Leads development of novel complex methodologies, troubleshooting & resolution of complex technical & 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 (i.e., evaluates aberrant results and data trends), anticipates and corrects potential issues, and able to appropriately guide study teams through complex issues resolution.
Leads internal and cross-functional organization initiatives, best practices and demonstrates internal and external influence.
Provides subject matter expertise, guidance and mentoring to colleagues. May have responsibility for dotted/direct line management of staff.
Must Have
PhD or equivalent in biology or analytical chemistry/chemistry with 2 to 6 years of experience
M.S with 3 to 6 OR B.S. with 7 to 10 years of relevant industry experience.
Minimum of 5-8 years of industry or bioanalytical experience with PK and/or immunogenicity assay development, validation, and sample analyses ligand binding (ELISA and ECL) methodologies.
Working knowledge of GxP regulations governing conduct of clinical trials and regulatory guidance and expectations relevant to regulated bioanalysis.
Subject matter expert in regulated bioanalysis of Biologics and understanding of bioanalytical techniques commonly used for Biomarkers.
In depth knowledge of GxP regulations governing conduct of clinical trials and regulatory guidance and expectations relevant to regulated bioanalysis.
Demonstrated ability to think strategically, work in a highly matrixed environment, and execute multiple projects simultaneously.
Highly effective communication skills: verbal, written, and presentation.
Demonstrated CRO management and outsourcing experience.
Experience with regulatory inspections.
Experience preparing regulatory submissions and addressing regulatory queries.
Understanding of clinical trial design and overall principles of clinical development and related disciplines (e.g., pharmacokinetics and clinical pharmacology, statistics, ADME, formulation and drug product).
Prior experience with training, mentoring, or managing colleagues.
Hands-on experience with the development, validation and troubleshooting of the methods for PK and immunogenicity (including the determination of assay cut points, tolerance, and sensitivity along with experience implementing ACE, BEAD, and SPEAD methodologies) and clinical sample analysis.
Hands-on experience with the development, validation, and troubleshooting of LC/MS quantitation of large molecules and immunocapturing hybrid assays.
Understanding of critical reagent generation & lifecycle management
Experience with biosimilars, gene therapy, multi-domain therapeutics, immunocapture, protein binding, cell-based assays and technologies such as RT-PCR, qPCR, ELISPOT, AMS and FACs.
Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
Other Job Details
Work Location Assignment: On Premise
Relocation assistance may be available based on business needs and/or eligibility.
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EEO & Employment Eligibility
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