Biologics & Immunogenicity Clinical Assay Manager

Position Purpose

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 support, oversight and management of external and internal partners involved in delivering quality, timely, and regulatory compliant PK and immunogenicity bioanalytical assays and data.

Organizational Relationships

• Reports to Biologics and Immunogenicity Group Lead, 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.

Primary Responsibilities

• 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 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  selection, qualification, performance evaluation, and periodic visits and audits of CRO laboratories conducting clinical PK and immunogenicity assays.

• 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.

Qualifications

Must Have

• PhD or equivalent in biology or analytical chemistry/chemistry with <2 years of experience

• B.S. with 5 to 6 years of relevant industry experience OR M.S with 3 to 5 years of relevant experience

• Minimum of 5+ 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.

• In depth knowledge in regulated bioanalysis of Biologics and Immunogenicity

• Demonstrated ability to think strategically, work in a highly matrixed environment, and execute multiple projects simultaneously.

• Highly effective communication skills:  verbal, written, and presentation. 

Nice to Have

• 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 tr