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 supporting key development decisions.
Role type
Senior IC bioanalytical development lead
Builds
Submission-ready bioanalytical data and documentation for IND/CTA and NDA/BLA/MAA filings
Domain
Biopharma / Drug Development / Bioanalysis
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
LC–MS/MS expertise, biologics bioanalysis, immunogenicity (ADA/NAb) interpretation, bioanalytical regulatory compliance, CRO/vendor management, assay validation strategy, data quality assurance
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; oversee end-to-end bioanalytical execution including protocols, sample analysis, and final reports; partner with Clinical Pharmacology and Regulatory Affairs on study design and submission components; align with DMPK/Nonclinical on translational PK needs; contribute to Trial Engine scaling by standardizing workflows and reporting conventions
Seniority
Senior, hands-on IC
