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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in bioanalytical strategies, including method development, validation, and regulatory compliance, while effectively managing CRO relationships and executing clinical trial processes. Proficient in chromatographic and mass spectrometry techniques, with a strong understanding of pharmacokinetics and biomarker analysis.
Highest-signal resume keywords
Bioanalytical Method DevelopmentChromatographic/Mass SpectrometryRegulatory Compliance (GxP)CRO ManagementClinical Trial Design
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
PK Assay DevelopmentImmunogenicity Assay ValidationBiomarker TechniquesFlow CytometryELISALC/MS QuantitationHPLC/UPLC/GC SeparationData Quality ReviewAnalytical Strategy ExecutionSample Preparation
Soft Skills
Effective CommunicationStrategic ThinkingProblem SolvingCollaborationProject Management
Tools & Technologies
Mass Spectrometry PlatformsBioanalytical SoftwareLaboratory Information Management Systems (LIMS)Statistical Analysis ToolsClinical Trial Management Systems (CTMS)
Industry Keywords
BioanalysisClinical DevelopmentRegulatory SubmissionsPharmacokineticsBiologicsSmall MoleculesADMEClinical PharmacologyGxP RegulationsBiomarker Analysis
About the role
Key responsibilities & impact- Support clinical strategies across all stages of drug development and post-marketing activities through scientific and technical leadership
- Serve as a clinical study team member and analytical subject matter expert
- Contribute to study protocol development and review, prepare submissions, address regulatory queries, implement bioanalytical strategies and assays, and deliver compliant data and reports
- Lead and oversee PK, PD, immunogenicity, and biomarker assay lifecycle management from early development through registration
- Execute analytical strategies, method design, development, validation, and data quality review
- Coordinate sample analyses and reports to meet program objectives and regulatory expectations
- Troubleshoot bioanalytical assays and resolve issues with CROs
- Serve as point of contact with external and internal laboratories
- Support or lead CRO laboratory selection, qualification, performance evaluation, and audits
- Support clinical trial conduct, including CRF and data setup, site laboratory manuals, sample management and reconciliation, bioanalytical planning and reporting, budgeting and invoicing, SOP compliance, and inspection readiness
- Develop best practices, processes, templates, and policies
- Maintain knowledge of chromatographic/mass spectrometry, ligand binding, biomarker techniques, regulatory guidance, and industry best practices
- Manage indirect bioanalytical study/program budget responsibilities and approve invoices
- Develop bioanalysis agreements with commercial and academic laboratories
- Participate in HGRAC task force, clinical sub-teams, and study teams
- Report to the Clinical Assay Group Lead and collaborate with Clinical Pharmacology, Clinical Operations, Statistics, Regulatory, Finance, CROs, clinicians, and external collaborators
Requirements
What you’ll need- PhD or equivalent in biology or analytical chemistry/chemistry; M.S. degrees considered based on relevant industry experience
- Minimum of 5–8 years of industry or bioanalytical experience with PK and/or immunogenicity assay and biomarker assay development, validation, and sample analyses
- Experience using chromatographic/mass spectrometry, ligand binding (ELISA and ECL), flow cytometry, FISH, or other relevant methodologies
- Working knowledge of GxP regulations governing clinical trials and relevant regulatory guidances and expectations
- Subject matter expertise in regulated bioanalysis of small organic molecules or biologics
- Understanding of bioanalytical techniques commonly used for biomarkers
- Demonstrated CRO management and outsourcing experience
- Experience with regulatory inspections, regulatory submissions, and addressing regulatory queries
- Understanding of clinical trial design, clinical development, pharmacokinetics, clinical pharmacology, statistics, ADME, formulation, and drug product
- Demonstrated ability to work strategically in a highly matrixed environment and execute multiple projects simultaneously
- Highly effective verbal, written, and presentation communication skills
- For biomarker focus: hands-on experience with flow cytometry, FISH, IHC, and NGS
- For biologics focus: PK and immunogenicity method development/validation/troubleshooting; assay cut points, tolerance, sensitivity; ACE, BEAD, SPEAD, RT-PCR, qPCR, ELISPOT, AMS, and FACs
- For small molecule focus: LC/MS quantitation; HPLC/UPLC/GC separation; sample preparation; mass spectrometry platforms; human ADME, protein binding, immunocapturing hybrid assays, LC-AMS, and HRMS
Benefits
Comp & perks- Equal opportunity employment
- Full-time employment