Clinical Assay Lead, Manager (Contractor), Shanghai or Beijing

Location: Shanghai, China; Beijing, China

Company

hirify.global develops medicines and supports clinical drug development programs.

What you will do

• Serve as a clinical study team member and analytical subject matter expert across study setup, conduct, protocol review, submissions, regulatory queries, bioanalytical strategies, assays, data, and reports.
• Lead PK, PD, immunogenicity, and biomarker assay lifecycle management from early development through registration, including method design, development, validation, sample analysis, and data quality review.
• Oversee internal and external laboratories and CROs, including laboratory selection, qualification, performance evaluation, audits, troubleshooting, and issue resolution.
• Support clinical trial documents and processes, including CRFs, data setup, site laboratory manuals, sample management, reconciliation, bioanalytical planning and reporting, budgeting, invoicing, SOP compliance, and inspection readiness.
• Develop best practices, processes, templates, and policies while maintaining knowledge of chromatographic and mass spectrometry detection, ligand-binding technologies, biomarker techniques, regulatory guidance, and industry practices.
• Manage indirect bioanalytical study budgets, develop agreements with commercial and academic laboratories, approve invoices, and collaborate with Clinical Pharmacology, Clinical Operations, Statistics, Regulatory, Finance, CROs, and external partners.

Requirements

• PhD or equivalent in biology, analytical chemistry, or chemistry required; an M.S. degree may be considered with relevant industry experience.
• 5–8 years of industry or bioanalytical experience in PK and/or immunogenicity assay and biomarker assay development, validation, and sample analysis.
• Experience with chromatographic and mass spectrometry methods, ligand-binding methods such as ELISA and ECL, or relevant methodologies including flow cytometry and FISH.
• Working knowledge of GxP regulations governing clinical trials and regulatory guidance and expectations for regulated bioanalysis.
• Subject matter expertise in regulated bioanalysis for small organic molecules or biologics, with understanding of commonly used biomarker techniques.
• Strategic thinking, ability to work in a highly matrixed environment, and ability to execute multiple projects simultaneously.
• Strong verbal, written, and presentation communication skills.
• For biomarker-focused work: hands-on development, validation, and troubleshooting experience with methods including flow cytometry, FISH, IHC, and NGS.
• For biologics-focused work: hands-on PK and immunogenicity method experience, including assay cut points, tolerance, sensitivity, ACE, BEAD, SPEAD, clinical sample analysis, critical reagent lifecycle management, and relevant technologies such as RT-PCR, qPCR, ELISPOT, AMS, and FACS.
• For small-molecule-focused work: hands-on LC/MS quantitation, HPLC/UPLC/GC separation, sample preparation, mass spectrometry detection, clinical sample analysis, human ADME, protein binding, immunocapture hybrid assays, LC-AMS, and HRMS.

Nice to have

• CRO management and outsourcing experience.
• Experience with regulatory inspections, regulatory submissions, and responses to regulatory queries.
• Understanding of clinical trial design, clinical development, pharmacokinetics, clinical pharmacology, statistics, ADME, formulation, and drug product.
• Experience training, mentoring, or managing colleagues.

Culture & Benefits

• Full-time contractor position supporting clinical development activities in China.
• Work involves collaboration across Clinical Pharmacology, Clinical Operations, Statistics, Regulatory, Finance, CROs, laboratories, and external collaborators.
• Work is governed by clinical SOPs, GxP requirements, regulatory expectations, and inspection-readiness standards.