Associate Director, Bioanalytical Development
Core
Lead bioanalytical strategy and delivery for assigned preclinical and clinical programs across small molecules and biologics, ensuring assays are fit for purpose and support key development decisions.
Role type
Senior IC bioanalytical development lead
Builds
Submission-ready bioanalytical data and documentation for PK/TK, metabolites, biologics, and immunogenicity studies
Domain
Biopharma, clinical development, bioanalysis
Required skills
LC–MS/MS expertise, biologics bioanalysis, immunogenicity (ADA/NAb), assay validation, CRO/vendor management, regulatory documentation, data quality management, sample logistics coordination
Preferred skills
Clinical study team integration, GCP/GCLP audit readiness, sample logistics and data flow for filings
Technologies
LC–MS/MS, bioanalytical software platforms
Responsibilities
Define assay plans and validation approaches for PK/TK, metabolites, biologics, and immunogenicity; Manage bioanalytical CROs and specialty labs for assigned workstreams; Oversee end-to-end bioanalytical execution including protocols, validation reports, and data review; Partner with Clinical Pharmacology and Clinical Development on study design and sampling strategies; Collaborate with Regulatory Affairs on submission components for IND/CTA and NDA/BLA/MAA activities; Support diligence and asset evaluation by reviewing bioanalytical packages
Seniority
Senior, hands-on IC
