Large Molecule Clinical Assay Lead, Associate Director
As a member of the Clinical Assay Group within Global Clinical Pharmacology, the Clinical Assay Lead plays 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 large molecule PK, PD, and immunogenicity analytical assays and data.
- 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 and oversees large molecule PK and immunogenicity (ADA and Nab) 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 PK, PD, and Immunogenicity assays.
- 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.
- Supports clinical trials and programs involving novel modalities, cross-company collaborations, and/or external partnerships in addition to Clinical Assay Group study responsibilities, which include 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.
- 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.
- 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.
- PhD or equivalent in biology or analytical chemistry/chemistry with 5+ years of industry or bioanalytical experience with PK and/or immunogenicity assay development, validation, and sample analyses using ligand binding (ELISA and ECL) methodologies, Master's degree with 7+ years OR Bachelor's degree with 9+ years.
- Recognized subject matter expert in regulated bioanalysis and understanding of bioanalytical techniques commonly used for Large Molecules.
- Expertise in development, validation and troubleshooting of complex methods for PK and immunogenicity assessment (including the determination of assay cut points, tolerance, and sensitivity along with experience implementing ACE, BEAD, and SPEAD methodologies and in clinical sample analysis.
- Strong understanding of critical reagent generation & lifecycle management.
- In depth knowledge and ability to provide interpretation of GxP regulations governing conduct of clinical trials and regulatory guidances and expectations relevant to regulated bioanalysis.
- Experience preparing regulatory submissions and addressing regulatory queries.
- Demonstrated ability to think strategically, work effectively in a highly matrixed environment, and execute multiple projects simultaneously.
- Demonstrated CRO management and outsourcing experience.
- Highly effective communication skills: verbal, written, and presentation.
- Understanding of clinical trial design, overall principles of clinical development, and related disciplines (e.g., pharmacokinetics and clinical pharmacology, statistics, immunology, human ADME, formulation and drug product).
- Experience with biosimilars, gene therapy, multi-domain therapeutics, human ADME, immunocapture, protein binding, cell based assays and technologies such as RT-PCR, qPCR, ELISPOT, and FACs.
- Direct experience interacting with regulatory authorities and supporting regulatory inspections.
- Prior experience with training, mentoring and managing colleagues.
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.Relocation support available
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