Director, Integrated Bioanalysis Oncology Development
Core
Leading end-to-end bioanalytical strategies for oncology programs, ensuring robust assay development and validation for PK, immunogenicity, and biomarker endpoints.
Role type
Director, Integrated Bioanalysis
Builds
Bioanalytical plans and data for complex modalities including ADCs, radio-conjugates, T cell engagers, biologics, and small molecules.
Domain
Biopharmaceuticals / Oncology / Bioanalysis
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Regulated bioanalysis strategy, complex biologics analysis, ADC/bioconjugate expertise, global regulatory submission experience, CRO management, assay transfer, data interpretation, LC-MS, flow cytometry, ELISpot, ddPCR, qPCR, RT-qPCR, viral/cytokine assays
Preferred skills
T cell engager experience, monoclonal antibody expertise, immunology background, operational process development
Technologies
LC-MS, flow cytometry, ELISpot, ddPCR, qPCR, RT-qPCR
Responsibilities
Define and drive bioanalytical plans for complex modalities; engage with CROs on assay transfer and validation; interpret complex datasets; contribute to regulatory submissions; represent IBA at internal and external forums; publish scientific work.
Seniority
Director, strategy & hands-on leadership