• JOB INFORMATIONJOB SUMMARYAs a member of the Clinical Assay Group within Development China Clinical Pharmacology, 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, immunogenicity and biomarker analytical assays and data (as relevant to Small Molecule, Biologics or biomarker).JOB RESPONSIBILITIES
• Serves as a member of the clinical study team and analytical 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 small or large molecule PK, PD, and immunogenicity (ADA and Nab) assay and biomarker assay lifecycle management from early stage to registration. Analytical strategy execution, method design, development, and validation, as well as data quality review will be involved. Corresponds sample analyses & reports 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 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 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 chromatographic separation/mass spectrometry based detection, ligand binding technologies & techniques or bioanalytical techniques commonly used for Biomarkers (as relevant to the role), global regulatory guidances & expectations, and industry best practices.

RESOURCES MANAGED

Indirect responsibility for the clinical budget allocated to bioanalytical support of the clinical study or program. Develop bioanalysis agreements with commercial and academic laboratories. Responsible for approval of invoices for work overseen. Member of HGRAC task force, Clinical sub-teams and study teams.

ORGANIZATIONAL RELATIONSHIPS

Reports to Clinical Assay Group Lead Frequent interaction with colleagues in Clinical Pharmacology, Clinicians, Contract Research Organizations (CROs), Clinical Operations, Statistics, Regulatory, Finance, and external collaborators, as appropriate.

As Specific to Biomarker:

Hands-on experience with the development, validation and troubleshooting of the methods commonly used for Biomarkers, including but limited to flow cytometry, FISH, IHC and NGS

As Specific to Biologics:

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. 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.

As Specific to Small Molecule:

Hands-on experience with the development, validation and troubleshooting of the methods for LC/MS quantitation, along with experience implementing HPLC/UPLC/GC separation, sample preparation techniques, mass spectrometry detection platforms and their application in clinical sample analysis. Experience with human ADME, protein binding, immunocapturing hybrid assays and technologies such as LC-AMS and HRMS.

PREFERRED QUALIFICATIONS (BASED ON THE POSITION LEVEL AND REQUIRED EXPERIENCE)

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.

QUALIFICATIONS / SKILLS

EDUCATION

PhD or equivalent in biology or analytical chemistry/chemistry. M.S. degrees will be considered based on relevant industry experience

BASIC QUALIFICATIONS

Minimum of 5-8 years of industry or bioanalytical experience with PK and/or immunogenicity assay and biomarker assay development, validation, and sample analyses using chromatographic/mass spectrometry, ligand binding (ELISA and ECL) or other methodologies like flow cytometry, FISH and etc. (as relevant to the role). Working knowledge of GxP regulations governing conduct of clinical trials and regulatory guidances and expectations relevant to regulated bioanalysis. Subject matter expert in regulated bioanalysis small organic molecules or Biologics and understanding of bioanalytical techniques commonly used for Biomarkers. In depth knowledge of GxP regulations governing conduct of clinical trials and regulatory guidances 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.

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