Biomarker Clinical Assay Lead, Director
As a member of the Clinical Assay Group within Global Clinical Pharmacology, the Biomarker Clinical Assay Lead will play a critical role in supporting clinical biomarker assay 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.
- Serves as a member of the clinical study team and biomarker 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.
As appropriate, additional responsibilities may include the following:
- Supports challenging clinical trials and programs involving novel modalities, cross-company collaborations and/or external partnerships.
- As SME, assists clinical pharmacology leads in conducting due diligence activities.
- Leads internal and cross-functional organization initiatives, development and implementation of the relevant policies and best practices, and demonstrates internal and external influence.
- Provides subject matter expertise, guidance and mentoring to colleagues.
PhD in biology, immunology or analytical chemistry/biochemistry or related field with a minimum of 10 years of experience, or MS with a minimum of 15 years of relevant industry or bioanalytical experience with novel technologies deployed in fit-for-purpose biomarker assay development, validation, and sample analyses using relevant methodologies.
- Recognized scientific and technical leadership and accomplishments in biomarker bioanalytics supported by extensive publications and presentations
- Subject matter expert in one or more technology platforms such as NGS, IHC, qPCR, FISH, FACS, and other cell based and/or circulating biomarker technologies.
- Expertise in development, validation and troubleshooting of complex fit-for-purpose biomarker methods in various matrices (including tissue) using broad range of methodologies and techniques for biomarker clinical sample analysis.
- In depth knowledge and ability to provide interpretation of GxP, CAP and CLIA regulations governing conduct of clinical trials and regulatory guidance’s and expectations relevant to regulated biomarker bioanalysis.
- Demonstrated ability to understand disease biology and how it applies to biomarker strategy, PK/PD relationships, dose selection and clinical development plans in multiple therapeutic areas including Rare Diseases, Gene Therapy, and Inflammation.
- Strong understanding of critical reagent generation & lifecycle management.
- Demonstrated CRO management and outsourcing experience.
- Direct experience interacting with regulatory authorities and supporting regulatory submissions & regulatory queries, and inspections.
- 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.
- Understanding of clinical trial design, overall principles of clinical development, and related disciplines (e.g., clinical pharmacology, PK/PD, biology, formulation and drug product).
- Good understanding of LBA and hybrid LBA-LCMS for protein biomarker analysis.
- Prior experience with training and mentoring colleagues.
- Certification in Clinical Lab Science (CLS) or American Society of Clinical Pathologist (ASCP) is a plus.
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.
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