Biomarker Clinical Assay Lead, Manager

ROLE SUMMARY

As a member of the Clinical Assay Group within Global Clinical Pharmacology, Biomarker 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 biomarker analytical assays and data.

ROLE 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 and review, preparing submissions, addressing regulatory queries, developing and implementing bioanalytical strategies & assays, and delivering regulatory compliant data and reports within program timelines.
• Leads development of novel complex fit-for-purpose biomarker 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 and oversees fit-for-purpose biomarker assay lifecycle management from early stage to registration encompassing analytical development and method design, validation, data quality review, corresponding sample analyses & reporting to meet evolving program objectives and regulatory expectations. Guides and leads study teams with respect to the selection and execution of the analytical strategy.
• Functions as key point of contact with external & 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 & 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 biomarker assays & techniques, global regulatory guidance's & expectations, and industry best practices.

BASIC QUALIFICATIONS

• PhD with experience in Clinical Laboratory Sciences, Molecular biology or related fields with 3+ years' experience in biomarker assay development, validation, and clinical laboratory sample analyses.
• Master's degree with 5+ years OR Bachelor's degree with 7+ years' experience in in biomarker assay development, validation, and clinical laboratory sample analysis.
• Certification in Clinical Lab Science (CLS) or American Society of Clinical Pathologist (ASCP) is a plus.
• Demonstrated knowledge and experience with development, validation and troubleshooting and use within clinical trials, of broad range of platform technologies (e.g. LBA, NGS, IHC, PCR, FISH, flow cytometry, other cell based and circulating biomarker technologies).
• Demonstrated ability to understand disease biology and how it applies to biomarker in multiple therapeutic areas including Rare Diseases, Gene Therapy, and Inflammation.
• Strong understanding of critical reagent generation & lifecycle management.
• 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 biomarker bioanalysis as to different technologies and context of use.
• Demonstrated ability to think strategically, work effectively in a highly matrixed environment, and execute multiple projects simultaneously.
• Highly effective communication skills: verbal, written, and presentation.

PREFERRED QUALIFICATIONS

• Demonstrated 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).
• Good understanding of hybrid LBA-LCMS for small and/or protein biomarker analysis.
• Experience preparing regulatory submissions and addressing regulatory queries.
• Prior experience with training and mentoring colleagues.

Other Job Details:

• Eligible for Employee Referral Bonus: YES

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