Director, Oncology Bioanalytical Strategy Lead
Core
Lead the design and implementation of robust bioanalytical strategies (PK, immunogenicity, biomarkers) for the oncology pipeline, serving as the primary interface for scientific oversight and delivery.
Role type
Senior IC bioanalytical strategy lead (oncology)
Builds
Bioanalytical assays and strategies for oncology therapeutic modalities
Domain
Biopharmaceuticals / Oncology / Bioanalysis
Required skills
Regulated bioanalysis strategy, complex biologics/ADCs expertise, project leadership, regulatory submission experience, assay transfer management, data interpretation, stakeholder management, resource prioritization
Preferred skills
Immunology background, experience with radioconjugates/T-cell engagers, publication history
Technologies
Ligand binding assays, LC-MS, ddPCR, qPCR, RT-qPCR, flow cytometry, ELISpot, viral assays, cytokine assays
Responsibilities
Design and implement bioanalytical strategies for oncology programs, collaborate with internal/external lab and CRO teams, manage stakeholder expectations, present at internal/external meetings, contribute to regulatory submissions (INDs, NDAs), interpret complex datasets
Seniority
Senior, hands-on IC